Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/302014 Class lI: PRODUCT Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment...Read More

Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2110-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...Read More

Company:Philips Ultrasound, Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. Recall Number Z-2109-2014 REASON Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0...Read More

Company:Hospira Inc.Date of Enforcement Report: 7/30/2014 Class lI: PRODUCT The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or...Read More

Company: Invacare CorporationDate of Enforcement Report: 7/30/2014 Class lI: PRODUCT MK5 NX Controller–Wheelchair controller Recall Number Z-2091-2014 REASON M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward...Read More

Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class I: PRODUCT DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. Recall Number Z-2068-2014 REASON Failure of the CO2 detector in...Read More

Company: GE Healthcare Date of Enforcement Report:7/30/2014 Class lI: PRODUCT GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Recall Number Z-2085-2014 REASON GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data...Read More