Company: Philips Medical Systems Date of Enforcement Report 5/4/2011 Class ll: PRODUCT MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to...Read More

Company: Hospira Inc. Date of Enforcement Report 5/4/2011 Class ll: PRODUCT GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; list 13092-04-01. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Recall # Z-1999-2011 REASON The software enables programming of the GemStar device for a Bolus Lower Lockout...Read More

Company: Gambro Renal Products, Inc. Date of Enforcement Report 5/4/2011 Class ll: PRODUCT Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Recall # Z-1901-2011 REASON Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro...Read More