Data Foundry

Medical device recalls 2019

GE Centricity PACS-IW versions 3 — Class II medical device recall Z-1781-2019

Terminated recall by GE Healthcare, LLC, reported 2019-06-19. There is a potential that one or more image series (i.e., all images within an image set) may be missing from

Recall numberZ-1781-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2019-05-22
Classified2019-06-13
Reported by FDA2019-06-19
Terminated2024-09-20
Quantity620 units
Serial numbers000282202-CENTRICITY, 000341097-CENTRICITY, 100009-1-CENTRICITY, 100020-1-CENTRICITY, 100021-1-CENTRICITY, 100065-1-CENTRICITY, 100088-1-CENTRICITY, 100156-1-CENTRICITY, 100166-1-CENTRICITY, 100199-1-CENTRICITY, 100378-1-CENTRICITY, 100458-1-CENTRICITY, 100468-1-CENTRICITY, 100485-1-CENTRICITY, 1005-1-CENTRICITY, 100511-1-CENTRICITY, 100580-1-CENTRICITY, 100582-1-CENTRICITY, 100589-1-CENTRICITY, 100603-1-CENTRICITY, 100609-1-CENTRICITY, 100639-1-CENTRICITY, 100645-1-CENTRICITY, 100663-1-CENTRICITY, 100664-1-CENTRICITY and 475 more

Product

GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

Reason for recall

There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

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-1781-2019. 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.