Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Syngo Imaging VB36D_HF02. Radiological image processing system. Recall Number Z-0319-2016 REASON To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. RECALLING FIRM/MANUFACTURER...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4. Recall Number Z-0337-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3-A. For home hemodialysis. Recall Number Z-0336-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3. For home hemodialysis. Recall Number Z-0335-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Recall Number Z-0327-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16...Read More

Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Recall Number Z-0326-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 323...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Recall Number Z-0325-2016 REASON When a fused series of a sagittal, coronal or radial multi station scan is generated...Read More

Company:Philips Electronics North America Corporation.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall Number Z-0320-2016 REASON The following MRx software issue has been identified: MRx model M3535A with software version F.03.06...Read More