Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 Recall Number Z-0473-2015 REASON Software defect RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/9/2014. Voluntary:...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454 Recall Number Z-0450-2015 REASON Software issues RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/4/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company:Vision Rt Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Recall Number Z-0464-2015 REASON Potential failure of AlignRT to assert interlock....Read More

Company: Abbott Molecular. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT Abbott m2000sp is intended use as an automated system for performing sample preparation for nucleic acid testing. Recall Number Z-0463-2015 REASON Abbott Molecular identified some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This may cause...Read More