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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration,...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 4/24/2013 Class ll: PRODUCT Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple...Read More

Company: Maquet Cardiovascular, LLC.Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for...Read More

Company: Horiba Instruments, Inc dba Horiba Medical .Date of Enforcement Report: 4/24/2013 Class ll: PRODUCT HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. Recall Number Z-1141-2013 REASON HORIBA Medical is informing all ABX PENTRA 400 Analyzer with...Read More

Company:GE HealthcareDate of Enforcement Report 4/24/2013 Class ll: PRODUCT GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server...Read More

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Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class Il: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1112-2013 REASON The recall was initiated because Carefusion has identified potential risk associated with bolus programming...Read More

Company:Carefusion Corp..Date of Enforcement Report 4/24/2013 Class I: PRODUCT Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. Recall Number Z-1098-2013 REASON The recall was initiated because Carefusion has received reports of a communication error on...Read More