Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/13/2011
Class ll:
PRODUCT
AExtended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace?? (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. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW). Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. EBW and NM EBW. Recall # Z-1819-2011
REASON
The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed for “Wall Thickening” actually represent a reduction in wall thickness from ES to ED.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated September 29, 2010. FDA initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,068 units
DISTRIBUTION
Nationwide and Internationally
