FDA recall, , Moderate risk
Allia Angiographic X-Ray System
The Allia IGS 3 Pulse angiographic X-ray system has an electrical cable issue that could cause electrical shock to service personnel.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC of Waukesha, Wisconsin is recalling certain Allia IGS Pulse, Allia IGS 3 Pulse, Allia IGS 5 Pulse, Allia IGS 7 Pulse, and Allia Moveo angiographic X-ray systems equipped with Gaia generators.
GE HealthCare has become aware of a potential issue affecting an electrical cable on these systems that could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
The recall began April 20, 2026, and was added to the FDA's Enforcement Report on June 5, 2026, with nationwide distribution in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Allia IGS 3 Pulse angiographic X-ray system
- UDI-DI
- 00195278719577
Allia IGS Pulse angiographic X-ray system
- UDI-DI
- 00195278827647
Allia Moveo angiographic X-ray system
- UDI-DI
- 00198953052488
Allia IGS 5 Pulse angiographic X-ray system
- UDI-DI
- 00195278719263
Allia IGS 7 Pulse angiographic X-ray system
- UDI-DI
- 00195278719720
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98880
- Recall numbers
- Z-2314-2026 to Z-2318-2026
All recalls from GE Medical Systems, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
