Notice names this product. GE Medical Systems’s Revolution Apex is named in FDA Class II recall Z-2154-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: UDI-DI: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN. Units affected: 24 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 …