Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Allia Moveo angiographic X-ray system recall: GE HealthCare has become aware of a potential issue affecting an electrical

Recall published 4 months ago

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.

The hazard: Electric shock hazard

This recall is about electric shock: the product can put current where a user’s hand is going to be.

What the notice says: 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.

Why it matters: The product can expose live parts, lose its earth connection or let current reach a surface a user touches. The risk is highest in a bathroom, a kitchen or outdoors, where someone is likely to be wet or standing on damp ground.

Symptoms and when to call a doctor

Do not touch someone who is still in contact with a live source — cut the power at the breaker first. Call 911 for any shock that caused unconsciousness, chest pain, an irregular heartbeat, burns, numbness or muscle pain. Even a shock that felt minor is worth a same-day check if it crossed the chest, because heart rhythm problems can appear a little later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2318-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Medical Systems, LLC
Product type
Medical devices
Units affected
3 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005
UPC codes
00198953052488

Products covered by this recall

Allia Moveo angiographic X-ray system

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00198953052488

Serial number

On the rating plate, often next to the date of manufacture.

  • C4-25-001
  • C4-25-002
  • C4-26-001
  • C4-26-00

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Shock

GE Medical Systems, LLC — This recall is about electric shock: the product can put current where a user’s hand is going to be.

  1. Unplug the product, or switch off its circuit at the breaker if it is hard-wired.
  2. Follow the remedy on this page and keep the model and serial numbers to hand.
  3. Do not use it outdoors, in a bathroom or anywhere damp while waiting for the remedy.
  4. Do not attempt a repair yourself unless the notice specifically describes a user-fitted kit.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.

Company contact: GE Medical Systems, LLC — 3000 N Grandview Blvd, Waukesha, WI, 53188-1615

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Medical Systems, LLC medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00198953052488. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Unplug the product, or switch off its circuit at the breaker if it is hard-wired.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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