RegWardenFDA facility compliance records
Recall

Class II — GE Healthcare, LLC

Recalling firmGE HealthCare Technologies Inc.
Registered facilityView this company's 50 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonGE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
ProductDiscovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Quantity1113 in total
DistributionNationwide Distribution
Initiated2019-02-12
Classified2019-06-19
Recall numberZ-1748-2019
InitiationFDA Mandated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — GE Healthcare, LLC (Z-1748-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82982/

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