FDA Medical devices recall ·
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and… recall
- Recall number
- Z-2150-2026
- Date
- (initiated March 26, 2026)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 38 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2150-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.