The Recall Desk
HighFDA (Devices)·Z-2314-2026·Announced 2026-06-17

GE Allia IGS 3 Pulse systems pose shock risk to servicers

Allia IGS 3 Pulse angiographic X-ray systems are being recalled because an electrical cable issue could expose service personnel to electrical shock while power is on. Nine units affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a stated electrical shock risk to service personnel, a risk of harm with no injuries reported in the source.

Plain-English summary

The Allia IGS 3 Pulse angiographic X-ray system, UDI-DI 00195278719577, is being recalled. The action covers nine units, identified by the serial numbers in the recall notice including M3-24-053, M3-24-124 and M3-25-029.

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. According to the manufacturer, 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 FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the UDI-DI and serial numbers in the recall notice and follow the instructions issued by GE HealthCare.

The recalled product

Product
Allia IGS 3 Pulse angiographic X-ray system
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Angiographic X-ray system
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • UDI-DI: 00195278719577
  • Serial Numbers: M3-24-053
  • M3-24-124
  • M3-25-029
  • M3-25-051
  • M3-25-053
  • M3-25-091
  • M3-25-098
  • M3-25-124
  • M3-26-010
  • M3-26-030

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

See all →

Same hazard · electrical shock

See all →