FDA recall Z-3170-2026

GE Healthcare · Class II · device

Product

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

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-3170-2026