Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Allia IGS 5 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

The defect here lets live parts become accessible, or defeats the earth connection that is supposed to make the product safe when something else fails.

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-2315-2026
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
121 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00195278719263; Serial Numbers: M2-23-039, M2-23-056, M2-24-004, M2-24-019, M2-24-020, M2-24-025, M2-24-030, M2-24-031, M2-24-032, M2-24-033, M2-24-034, M2-24-037, M2-24-038, M2-24-039, M2-24-040, M2-24-046, M2-24-057, M2-24-062, M2-24-064, M2-24-066, M2-24-069, M2-24-071, M2-24-077, M2-24-078, M2-24-080, M2-24-083, M2-25-003, M2-25-004, M2-25-005, M2-25-011, M2-25-013, M2-25-015, M2-25-017, M2-25-019, M2-25-023, M2-25-024, M2-25-025, M2-25-026, M2-25-028, M2-25-032, M2-25-036, M2-25-037, M2-25-039, M2-25-040, M2-25-041, M2-25-042, M2-25-043, M2-25-046, M2-25-048, M2-25-049, M2-25-056, M2-25-057, M2-25-058, M2-25-062, M2-25-065, M2-25-067, M2-25-072, M2-25-074, M2-25-077, M2-25-078, M2-25-080, M2-25-250, M2-25-300, M2-26-002, M2-26-004, M2-26-006, M2-26-007, M2-UP2502, M3-22-012, M3-23-117, M3-24-019, M3-24-021, M3-24-023, M3-24-034, M3-24-052, M3-24-061, M3-24-074, M3-24-079, M3-24-086, M3-24-090, M3-24-094, M3-24-095, M3-24-097, M3-24-099, M3-24-101, M3-24-104, M3-24-111, M3-24-120, M3-24-128, M3-24-136, M3-24-137, M3-24-141, M3-24-143, M3-24-149, M3-24-151, M3-24-156, M3-24-159, M3-24-161, M3-24-163, M3-24-165, M3-24-168, M3-24-169, M3-24-172, M3-24-175, M3-25-003, M3-25-012, M3-25-017, M3-25-020, M3-25-027, M3-25-036, M3-25-061, M3-25-063, M3-25-069, M3-25-074, M3-25-076, M3-25-079, M3-25-080, M3-25-084, M3-25-085, M3-25-088, M3-25-089, M3-25-094, M3-25-104, M3-25-106, M3-25-107, M3-25-115, M3-25-118, M3-25-119, M3-25-120, M3-25-128, M3-25-130, M3-25-132, M3-25-145, M3-25-147, M3-25-148, M3-25-149, M3-25-150, M3-25-151, M3-26-002, M3-26-003, M3-26-005, M3-26-007, M3-26-021, M3-26-024, M3-26-027, M3-26-028, M3-26-033, M3-26-034, M3-UP2501, M3-UP2503
UPC codes
00195278719263

Products covered by this recall

Allia IGS 5 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.

  • 00195278719263

Serial number

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

  • M2-23-039
  • M2-23-056
  • M2-24-004
  • M2-24-01

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 — The defect here lets live parts become accessible, or defeats the earth connection that is supposed to make the product safe when something else fails.

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

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.

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 00195278719263. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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