Company: Hospira Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Recall Number Z-1847-2013 REASON The devices secondary audio signal fails to...Read More

Company:Picis Inc. Date of Enforcement Report:8/7/2013 Class ll: PRODUCT Picis ED Pulsecheck – EMR Software Application – 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. Recall Number Z-1814-2013 REASON Notes...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report: 8/7/2013 Class ll: PRODUCT AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. Recall Number Z-1834-2013 REASON The recall was initiated because Beckman Coulter has identified a software error on...Read More