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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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....Read More

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...Read More

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....Read More

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...Read More