Allia recallZ-2318-2026 · GE Medical Systems, LLC · initiated Apr 20, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue 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.
FDA root cause category: Device Design
What the company is doing
An URGENT MEDICAL DEVICE CORRECTION dated 4/20/26 was sent to customers. Actions to be taken by Customer/User You can continue to use your system. As a reminder, qualified service personnel must follow the Service Manual applicable to your system and use the appropriate personal protective equipment (PPE) for electrical hazards when performing any activity inside the cabinet while power is ON. If any abnormal condition is observed on the Iris Power Cable during servicing, such as loose or visibly exposed wires, qualified service personnel must follow the Electrical Lockout/Tagout Procedure as described in Service Manual. Please ensure that all potential users and service personnel in your facility are made aware of this safety notification and the recommended actions and post this letter in a visible location near the C-FRT cabinet. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 18014 Digital Response Form or print, fill out manually, scan, and email to [email protected].
Recall details
- Recall number
- Z-2318-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 20, 2026
- Posted by the FDA
- Jun 5, 2026
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 3 units
- Product code
- OWB
- FDA submissions
- K251199
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Allia Moveo angiographic X-ray system
Code information (models, lots, serial numbers)
UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Allia MoveoGe Medical Systems · System, X-Ray, Angiographic1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98880).
- Z-2314-2026 · Open, ClassifiedAllia IGS 3 Pulse angiographic X-ray system
- Z-2315-2026 · Open, ClassifiedAllia IGS 5 Pulse angiographic X-ray system
- Z-2316-2026 · Open, ClassifiedAllia IGS 7 Pulse angiographic X-ray system
- Z-2317-2026 · Open, ClassifiedAllia IGS Pulse angiographic X-ray system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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