Food, drugs, devices › GE Healthcare
Device recall: Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical
GE Healthcare (Chicago, IL) initiated this device recall on 31 Jul 2026; FDA lists 6 product records under event 99661, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Healthcare has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, Chicago, IL.
Reason for recall
"Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care."
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3166-2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions | 1856 systems | Class II | Ongoing | 23 Sep 2026 |
| Z-3167-2026 | Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions | 1298 systems | Class II | Ongoing | 23 Sep 2026 |
| Z-3168-2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions | 1443 systems | Class II | Ongoing | 23 Sep 2026 |
| Z-3169-2026 | Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions | 116 systems | Class II | Ongoing | 23 Sep 2026 |
| Z-3170-2026 | Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions | 169 systems | Class II | Ongoing | 23 Sep 2026 |
| Z-3171-2026 | Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions | 250 systems | Class II | Ongoing | 23 Sep 2026 |
Context
Other enforcement events for GE Healthcare
All 44 events for GE Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.