CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Revolution Apex, X-ray Computed Tomography recalled
GE Medical Systems is recalling Revolution Apex, X-ray Computed Tomography, distributed nationwide in the US. The recall was initiated on 26 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2154-2026
- FDA event ID
- 98738
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Mar 2026
- FDA classified
- 8 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 26 Mar 2026 | Recall initiated by company | |
| 8 May 2026 | Classified by FDA | +43 days |
| 20 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 98738This product is part of a recall event; the main page for the event is Revolution CT ES, X-ray Computed Tomography recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Revolution CT ES, X-ray Computed Tomography recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Revolution Ascend, computed tomography recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide | |
| CLASS II | Revolution Apex Select, X-ray Computed Tomography recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Revolution Apex Elite, X-ray Computed Tomography recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Revolution Apex Plus, X-ray Computed Tomography recalled | GE Medical Systems | Other | Nationwide | |
| CLASS II | Revolution CT, x-ray computed tomography recalled by GE Medical Systems | GE Medical Systems | Other | Nationwide |
More recalls from GE Medical Systems
All 160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR220amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Optima XR200amx, Mobile Digital-Ready Radiographic System recalled | GE Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Giraffe OmniBed Field Replaceable Unit (FRU) recalled | GE Medical Systems | Other | Nationwide |
| Device | CLASS II | Allia IGS 7 Pulse angiographic X-ray system recalled | GE Medical Systems | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |