Day

April 24, 2013
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
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

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.