Company: Celera Corporation.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0. Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual Recall Number B-0993-14 REASON ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed.....Read More

Company: Terumo BCT, Inc.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT TerumoBCT, Lakewood, CO 80215 USA. Catalog No: 6100 Spectra Optia Apheresis System Recall Number B-0995-14 REASON Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback, were distributed. RECALLING FIRM/MANUFACTURER Terumo BCT, Inc., Lakewood, CO on 8/27/2014 Voluntary: Firm Initiated recall...Read More

Company: Spacelabs Healthcare Inc.Date of Enforcement Report:10/1/2014 Class lII: PRODUCT Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/1/2014 Class lI: PRODUCT The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Recall Number Z-2680-2014 REASON Siemens discovered that an unlikely...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report: 10/1/2014 Class lI: PRODUCT Artis zee and Artis zeego systems. x-ray, angiographic system Recall Number Z-2569-2014 REASON There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances,...Read More