Revolution CT ES — Class II medical device recall Z-2153-2026
Ongoing recall by GE Medical Systems, LLC, reported 2026-05-20, distributed nationwide. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison H
| Recall number | Z-2153-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2026-03-26 |
| Classified | 2026-05-08 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 00840682123471 |
| Serial numbers | REVV82100016CN, REVV82100027CN, REVV82100031CN, REVV82200014CN, REVV82200017CN, REVV82200046CN, REVV82200047CN, REVV82200058CN, REVV82400005CN, REVV82400010CN |
| Model numbers | 5590000-15 |
Product
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Reason for recall
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2153-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.