Data Foundry

Medical device recalls 2024

GE Healthcare Centricty PACS — Class II medical device recall Z-3214-2024

Ongoing recall by GE Healthcare, reported 2024-10-02. GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches th

Recall numberZ-3214-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, Chicago, IL, United States
Recall initiated2024-08-05
Classified2024-09-24
Reported by FDA2024-10-02
Quantity2,138 units
UPC / GTIN / UDI-DI00082403010015, 00082455050069, 00082455050076, 00082455170088, 00082455190147, 00082499100188, 00082499100386, 00082499130826, 00082499250135, 00082499260011, 00840682104807, 00840682124430, 00840682145572

Product

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

Reason for recall

GE 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3214-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.