RegWardenFDA facility compliance records
Recall

Class II — GE Healthcare

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 has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.
ProductGE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Quantity2138 units
DistributionWorldwide distribution.
Initiated2024-08-05
Classified2024-09-24
Recall numberZ-3214-2024
InitiationVoluntary: Firm initiated

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 (Z-3214-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95243/

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