FDA recall Z-3167-2026

GE Healthcare · Class II · device

Product

Enterprise Archive V8, 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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-07-31
Report date
2026-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3167-2026