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Recall Observatory FDA recall evidence

Device product

Revolution CT 160 1.5D STD WAUK

Z-2582-2018

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-2582-2018

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: Model Number 5590000-6. Serial number REVVX1800021CN (System ID 812842REV, UDI 01008406821185521118020021REVVX1800021CN), Serial Number REVVX1800004CN (System ID 269375REVOCT, UDI 01008406821185521118010021REVVX1800004CN).

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).