RecallReported September 23, 2026
Class II recall by GE Healthcare
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA's enforcement report of September 23, 2026 lists a Class II recall by GE Healthcare of Chicago, IL. Product: Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions. Status: Ongoing.
On the record
- Recalling firm
- GE Healthcare
- Location
- Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3167-2026
- Product type
- Devices
- Recall initiated
- 2026-07-31
- Reported by FDA
- 2026-09-23
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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