Device product
Philips Healthcare System X-ray Tomography Computed :
Z-0375-2017
Product summary
- Event
- Event 75551
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1363
- Official record key
device-enforcement:Z-0375-2017
Official wording
Reason: It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
Code information: Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, Brilliance Big Bore.
Distribution pattern: USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
Derived failure modes
-
Unknown
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.