By

Amy Sellers
Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Emotion 6 (Model 10165888) Recall Number: Z-2472-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Perspective 16 (Model 10891666) Recall Number: Z-2475-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:ELITech Clinical Systems SASDate of Enforcement Report 8/8/2018 Class lI: PRODUCT ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 Recall Number: Z-2591-2018 REASON ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class lI: PRODUCT SOMATOM Scope Power (Model 10967888) Recall Number: Z-2477-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...
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Company: Abbott Laboratories, Inc. Date of Enforcement Report 8/1/2018 Class lI: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...
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Company:Human Design Medical Llc Date of Enforcement Report 8/1/2018 Class lII: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware upgrade...
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Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/25/2018 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has learned...
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Company: Forte Automation Systems Inc. Date of Enforcement Report 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...
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What concerns FDA when conducting a benefit-risk assessment of medical devices?  The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...
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Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...
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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: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: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: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: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: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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The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare.  There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians.  The FDA wants to regulate...
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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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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...
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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 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 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: 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: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 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 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 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 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.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 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: 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: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 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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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 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: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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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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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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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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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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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: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: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: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: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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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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