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...Read More

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,...Read More

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...Read More

Our newsletter in pdf form lists items added to the web site from mid-April 2017 through June 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones. SoftwareCPR-June2018NewsletterRead More

Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...Read More

Baxter (Claris Injectables Ltd.) Product: drug manufacturing facility Date:7/5/18 Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

For information on FDA eSubmitter downloading and installation see the link. Let’s save the trees folks…Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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....Read More

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...Read More

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:...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More