Z-2318-2026Class II

Allia Moveo angiographic X-ray system

Name: Z-2318-2026 Allia Moveo angiographic X-ray system
Creator: GE Medical Systems, LLC
Published: 2026-04-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-04-20 / Open, Classified / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Allia Moveo angiographic X-ray system on 2026-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2318-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-20
Posted: 2026-06-05
Recalling firm: GE Healthcare
Product: Allia Moveo angiographic X-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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].
Quantity in commerce: 3 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2318-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2314-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2315-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2316-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2317-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2318-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code OWB

K251199Class IIAllia MoveoGE Medical Systems SCS / cleared 2025-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)