Company:Animas Corp Date of Enforcement Report 4/18/12 Class ll: PRODUCT OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Part number 101420-00, 10142100, 101422-00, 101424-00, 101425-00, 100430-00, 100431-00, 100432-00, 100434-00, 100435-00, 101420-98, 101421-98, 101422-98, 101424-98, 101425-98, and 10050000. Recall # Z-1376-2012 REASON There is an error in the pump...Read More

Company:Philips Healthcare Inc. Date of Enforcement Report 4/18/12 Class ll: PRODUCT MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 4/18/12 Class ll: PRODUCT GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended...Read More

Company:Siemens Healthcare Diagnostics, Inc.Date of Enforcement Report 4/18/12 Class ll: PRODUCT EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included...Read More

Company:Baxa Corp. Date of Enforcement Report 4/18/12 Class ll: PRODUCT Pharmacy compounding system. It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients. 2 model numbers 2400 D and 2400 M. Recall #...Read More