Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images....Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.. Recall Number Z-0862-2016 REASON Siemens is releasing...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips IntelliVue Measurement Module X1 Model: M3001A. Recall Number Z-0853-2016 REASON The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare IntelliVue Info Center iX, A.0 866023 Recall Number Z-0856-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary:...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). Recall Number Z-0857-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.. RECALLING FIRM/MANUFACTURER Philips Medical Systems,...Read More

Company: Regulatory Insight, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Recall Number Z-0753-2016 REASON It was discovered that the Remote Touch...Read More

Company: Regulatory Insight, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system. Recall Number Z-0803-2016 REASON The Firm has discovered a Software bug. RECALLING FIRM/MANUFACTURER Olympus Scientific Solutions Americas, Waltham,MA on 2/19/2016. Voluntary: Firm Initiated recall is...Read More