Recall Z-3166-2026— GE Healthcare

Name: FDA recall Z-3166-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, initiated 2026-07-31. It names 2 FDA 510(k) clearances: K110875, K043415. Product: Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions. Reason: 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..

Recalling firm: GE Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K110875 — CENTRICITY PACSGE Healthcare·cleared 2011-05-05
K043415 — CENTRICITY PACS SYSTEMGe Medical Systems Information Technologies·cleared 2005-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.