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Recall Observatory FDA recall evidence

Device product

Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring

Z-2580-2018

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-2580-2018

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 5454001-170. Serial Number (System ID Number): CJRPX1800016CN ( 4550966PT11), CJRPX1800017CN (561422MI), CJRPX1800018CN (617726PET1EB), CJRPX1800021CN (404616DMI)

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).