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Recall Observatory FDA recall evidence

Device product

CT Goldseal Optima CT 600

Z-2583-2018

May 24, 2018

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 80484
Status
Terminated
Classification
Class II
Quantity
42 units total
Official record key
device-enforcement:Z-2583-2018

Official wording

Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Code information: Serial Number 51941YC3, System ID Number 406434660

Distribution pattern: Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).