GE Medical Systems, LLC: Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems, LLC
- Product
- Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-03-26
- Code info
- UDI-DI: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
- Product quantity
- 38 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 98738
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