Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Allia IGS 7 Pulse 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-2316-2026
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
35 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007
UPC codes
00195278719720

Products covered by this recall

Allia IGS 7 Pulse 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.

  • 00195278719720

Serial number

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

  • D3-23-024
  • D3-23-029
  • D3-24-001
  • D3-24-00

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. Check for scorch marks, a warm plug or a damaged cord, and tell the company if you find any — it affects how they handle the claim.
  3. Follow the remedy on this page and keep the model and serial numbers to hand.
  4. Do not use it outdoors, in a bathroom or anywhere damp while waiting for the remedy.

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.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • 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.

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 00195278719720. 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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