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Recall Observatory FDA recall evidence

Device product

Philips Healthcare System X-ray Tomography Computed :

Z-0375-2017

March 15, 2016

Class II

Product summary

Firm
Philips Electronics North America Corporation
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

    reason.no_named_rule · v1.0.0

    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.