Company: Philips Healthcare.
Date of Enforcement Report 12/8/2010
Class ll:

PRODUCT
Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0133-2011

REASON
Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4×4.5 (18mm). If the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to appear in axial images.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters dated July 29, 2010 and August 23, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16 units

DISTRIBUTION
CA, DE, IN, OR, MA, NV, TN, Canada and Australia