Company: Philips Medical Systems (Cleveland) Inc.
Date of Enforcement Report: 9/7/05
Class:II
PRODUCT
a) Brilliance CT System, 40 channel configuration
using version 1.2 software, Recall # Z-1409-05;
b) Brilliance CT System, 16 Power configuration
using version 1.2 or 1.2.1 software,
Recall # Z-1410-05;
c) Brilliance 16, 10, and 6 configuration
(water cooled version) using 1.0. 1.1, 1.2,
1.2.2, or 1.2.4 software, Recall # Z-1411-05;
d) Brilliance CT system, 16, 10, and 6 configuration
(air cooled version) using version 1.2 or
1.2.1 software, Recall # Z-1412-05;
e) MX8000IDT CT Scanner using version 2.5.5,
3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software,
Recall # Z-1413-05;
f) MX8000 Dual v.EXP CT Scanner using version 2.5.
software, Recall # Z-1414-05;
g) Extended Brilliance Workspace using 1.x or 2.x
software, Recall # Z-1415-05;
h) MxView using version 5.0, 5.0.1, or 4.1
software, Recall # Z-1416-05;
i) Gemini PET/CT system, Dual Configuration,
Recall # Z-1417-05;
j) Gemini 16 PET/CT system, Slice Configuration,
Recall # Z-1418-05
REASON
When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
CODE
All codes
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters dated March 11, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,130 units
DISTRIBUTION
Nationwide and Internationally
