Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/13/2013
Class ll:
PRODUCT
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall Number Z-0906-2013
REASON
Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 9/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,580 units
DISTRIBUTION
Nationwide and Internationally
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