Enterprise Archive V8, software product for receiving recall
GE Healthcare recalled Enterprise Archive V8, software product for receiving on September 23, 2026 because of under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. It was sold nationwide.
Why it was recalled
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's recalled
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Quantity: 1298 systems
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- GE Healthcare, Chicago, IL
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide - US Nationwide distribution. - Status
- Ongoing
- Recall number
- Z-3167-2026
- Source
- U.S. Food and Drug Administration
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