FDA-Device2026-09-23Class IIPROCESSING DEFECT

GE Healthcare Workflow Core Services V8 recalled for patient data mix-up risk

LABEL MIX UPNationwide distributionMedical devices

What this means

GE Healthcare's Workflow Core Services V8 software can sometimes mix up patient imaging data during migration from older systems. When this happens, a patient's medical images may appear under another patient's record, potentially leading to wrong diagnoses or delayed care.

  • Contact GE Healthcare immediately if your facility uses Workflow Core Services V8
  • Check with your IT or radiology department to see if your system is affected
  • Work with GE on a corrective update or migration verification process
  • Review recent patient records to confirm data accuracy
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The agency's original wording
Hazard

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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution.
Affected count
169 systems
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3170-2026

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