Company: Respironics California Inc. (a division of Philips Healthcare) Date of Enforcement Report 11/19/2014 Class I: Date Recall Initiated: September 17, 2014 PRODUCT Esprit V1000 and V200 Ventilators, Model V1000 and V200, Installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits ? See complete listing of serial numbers. Manufactured and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures....Read More

Company:Maquet Cardiovascular Us Sales, Llc. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to...Read More

Company: Integra LifeSciences Corp. Date of Enforcement Report 11/19/2014 Class lI: PRODUCT Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 Recall Number Z-0201-2015 REASON ntegra LifeSciences Corporation received 2 complaints that...Read More