The Recall Desk
HighFDA (Devices)·Z-2316-2026·Announced 2026-06-17

[pending] Allia IGS 7 Pulse angiographic X-ray system

Pending LLM rewrite. Source: FDA_DEVICE Z-2316-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

Product
Allia IGS 7 Pulse angiographic X-ray system
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Devices

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 (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

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