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GE Allia IGS 3 Pulse Angiographic X-ray System
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MEDICAL DEVICE RECALLMODERATE

GE Allia IGS 3 Pulse Angiographic X-ray System

GE recalls Allia IGS 3 Pulse X-ray systems over electrical shock risk to service personnel.

What to do

If you are a service technician or facility that maintains an Allia IGS 3 Pulse system with a Gaia generator, contact GE HealthCare immediately for instructions on safe servicing and to schedule a corrective action. Do not perform installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on until the issue is resolved.

Recalled
Listed
Updated
Recall No.
Z-2314-2026
Agency
FDA
Firm
GE Medical Systems, LLC
Recall ID
98880
Status
ONGOING

Why it was recalled

GE HealthCare is recalling the Allia IGS 3 Pulse angiographic X-ray system because an electrical cable issue in systems equipped with Gaia generators could pose a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting inside the C-FRT cabinet while power is on.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Allia IGS 3 Pulse angiographic X-ray systemZ-2314-202600195278719577
Allia IGS Pulse angiographic X-ray systemZ-2317-202600195278827647
Allia Moveo angiographic X-ray systemZ-2318-202600198953052488
Allia IGS 5 Pulse angiographic X-ray systemZ-2315-202600195278719263
Allia IGS 7 Pulse angiographic X-ray systemZ-2316-202600195278719720

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification