CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Allia Moveo angiographic X-ray system recalled by GE Medical Systems

GE Medical Systems is recalling Allia Moveo angiographic X-ray system, distributed nationwide in the US. The recall was initiated on 20 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

Quantity recalled3 units

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-2318-2026
FDA event ID: 98880
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 20 Apr 2026
FDA classified: 5 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

20 Apr 2026	Recall initiated by company
5 Jun 2026	Classified by FDA	+46 days
17 Jun 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 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.

Product as listed by the FDA

Allia Moveo angiographic X-ray system

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005

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

4 other products · FDA event 98880

This product is part of a recall event; the main page for the event is Allia IGS 3 Pulse angiographic X-ray system recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026	CLASS II	Allia IGS 3 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026	CLASS II	Allia IGS Pulse angiographic X-ray system recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
17 Jun 2026	CLASS II	Allia IGS 5 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026	CLASS II	Allia IGS 7 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide

More recalls from GE Medical Systems

All 160

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Optima XR240amx, Mobile Digital Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR220amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR200amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Giraffe OmniBed Field Replaceable Unit (FRU) recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	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
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide