The Enforcement Report for the week of March 6, 2013, lists the ongoing recall of the Mx8000 IDT whole body computed tomography x-ray system distributed by Philips Medical Systems, Highland Heights, Ohio.
The Brilliance scanners are computed tomography x-ray systems with multi-slice capabilities of up to 16 slices, which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
It initiated the Class II Recall of 1,474 units on September 18, 2012 because the low contrast pins in the image quality (IQ) phantom deteriorate over time. This prevents the customers from doing the daily image quality checks as defined in the current Instructions for Use (IfU).
Worldwide and nationwide distribution includes Kansas, New York, and the countries of Albania, Algeria, Australia, Belgium, Egypt, France, Germany, the Netherlands, New Zealand, and more.
Click here to read the full report.