Company:Philips Medical Systems (Cleveland) Inc.
Date of Enforcement Report 6/13/12
Class ll:
PRODUCT
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311. Recall # Z-1791-2012
REASON
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest score for severity and probability using the risk analysis process: – Calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 8, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
241 units
DISTRIBUTION
Nationwide and Internationally
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