Company: Toshiba American Medical Systems IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. Recall Number Z-1714-2014 REASON Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been...Read More

Company: Spacelabs Healthcare Inc Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Spacelabs Medical Ultraview SL” Command Module, Model 91496. Detector and alarm, arrhythmia. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report:6/11/2014 Class lI: PRODUCT IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. Recall Number Z-1678-2014 REASON During SPECT reconstructions using Attenuation Correction and Scatter...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/11/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 — For in vitro quantitative measurement of a variety of analytes of clinical interest — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or...Read More

Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. Recall Number Z-1707-2014 REASON When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended...Read More