Tag

recall

Software Recall

Company: Tandem Diabetes Care Inc. Date of Enforcement Report 7/25/2018 Class II: PRODUCT t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Recall Number: Z-2471-2018 REASON The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide...
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Company: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Date of Enforcement Report: 7/25/2018 Class II: PRODUCT T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)Product Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy....
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Company: Intel-GE Care Innovations LLC Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the...
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Company: Zeiss, Carl Inc. Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Recall Number: Z-2441-2018 REASON Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users...
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/25/2018 Class lI: PRODUCT RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)Product Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall...
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Company:Zeiss, Carl Inc. Date of Enforcement Report 7/25/2018 Class lI: PRODUCT Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Recall Number: Z-2441-2018 REASON Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to...
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Company:Intel-GE Care Innovations LLC Date of Enforcement Report 7/25/2018 Class lI: PRODUCT Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home....
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Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Date of Enforcement Report 7/25/2018 Class lI: PRODUCT T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity....
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Company:Tandem Diabetes Care Inc. Date of Enforcement Report 7/25/2018 Class lI: PRODUCT t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Recall Number: Z-2471-2018 REASON The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate...
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Company: Steris Corporation Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in...
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Company: Ion Beam Applications S.A. Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number: Z-2424-2018 REASON Correction vector confirmation message...
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Company:Steris Corporation Date of Enforcement Report 7/18/2018 Class lI: PRODUCT Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in the...
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Company:Ion Beam Applications S.A. Date of Enforcement Report 7/18/2018 Class lI: PRODUCT Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number: Z-2424-2018 REASON Correction vector confirmation message is...
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Company: Medtronic Inc. Date of Enforcement Report: 7/11/2018 Class II: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting...
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Company: GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...
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Company:Medtronic Inc. Date of Enforcement Report 7/11/2018 Class lI: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen,...
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Company:Spacelabs Healthcare, Ltd Date of Enforcement Report 8/10/2018 Class l: PRODUCT The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with or...
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Company:GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class lI: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zeego, Material no. 10280959 Recall Number: Z-2314-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee MP, Material no. 10094139,, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2313-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2311-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2312-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2310-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2308-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2309-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2307-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2305-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2306-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2304-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2303-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report: 7/4/2018 Class II: PRODUCT RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the...
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Company: Ion Beam Applications S.A. Date of Enforcement Report 7/4/2018 Class II: PRODUCT The Proton Therapy System – Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) Recall Number: Z-2284-2018 REASON TBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2303-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zeego, Material no. 10280959 Recall Number: Z-2314-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2304-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2306-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2305-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2307-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2309-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2308-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2310-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2312-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2311-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee MP, Material no. 10094139,, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2313-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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Company: Ion Beam Applications S.A.Date of Enforcement Report 7/4/2018 Class lI: PRODUCT The Proton Therapy System – Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) Recall Number: Z-2284-2018 REASON TBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the...
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Company: RAYSEARCH LABORATORIES AB.Date of Enforcement Report 7/4/2018 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed...
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Company:  Draeger Medical, Inc. Date of Enforcement Report:  6/27/2018 PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage:  Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification....
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Company: Cyberonics, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT VNS Therapy Programmer, Model 3000, v1.0 System Recall Number: Z-2255-2018 REASON Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: ” Delivery of...
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Company:C.R. Bard, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018 REASON Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.. RECALLING FIRM/MANUFACTURER C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...
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Company: Datex-Ohmeda, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven...
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Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic...
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Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring,...
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Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders....
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Company:Cyberonics, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT VNS Therapy Programmer, Model 3000, v1.0 System Recall Number: Z-2255-2018 REASON Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: ” Delivery of more...
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Company:C.R. Bard, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018 REASON Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.. RECALLING FIRM/MANUFACTURER C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, Recall Number:...
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Company:Datex-Ohmeda, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...
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Company:Shimadzu Medical Systems. Date of Enforcement Report 6/20/2018 Class lI: PRODUCT Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is...
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Company:CellaVision AB. Date of Enforcement Report 6/20/2018 Class lI: PRODUCT CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies...
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Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...
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Company:Draeger Medical Systems, Inc. Date of Enforcement Report 6/13/2018 Class l: PRODUCT Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of...
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Company:GE Healthcare Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks...
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Company:Invivo Corporation. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Recall Number: Z-2115-2018 REASON While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control...
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Company:Ion Beam Applications S.A.. Date of Enforcement Report 6/13/2018 Class lI: PRODUCT 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system. Recall...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.. Recall Number: Z-2050-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/13/2018 Class lI: PRODUCT nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Now, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1939-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/62018 Class lI: PRODUCT SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1940-2018 REASON There is a potential for a software issue that may cause the need for necessary patient...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicBrainEXProduct Usage:nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Recall Number: Z-2044-2018 REASON An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or...
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Company:NordicNeuroLab AS Date of Enforcement Report 6/6/2018 Class lI: PRODUCT nordicTumorEx 1.0nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/30/2018 Class lI: PRODUCT Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1930-2018 REASON Possibility that the Biograph Horizon systems performing CT retrospective...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.20 US: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex 7.XX ROW, Product Code 114870: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or...
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Company:Baxter Healthcare CorporationDate of Enforcement Report 5/30/2018 Class lI: PRODUCT Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms...
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