FDAClass II · Medical device · Recall Z-2314-2026 · Recalled June 17, 2026

Allia IGS 3 Pulse angiographic X-ray system recall — GE Medical Systems, LLC

Agency report date: June 17, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Allia IGS 3 Pulse angiographic X-ray system
Company / brand: GE Medical Systems
Lot / serial / date codes: 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: Worldwide - US Nationwide distribution.

Agency product description and boundaries

Allia IGS 3 Pulse angiographic X-ray system

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Allia IGS 3 Pulse angiographic X-ray system recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2314-2026
Brand: All GE Medical Systems recalls
Classification: Class II
Units affected: 9 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Allia IGS 3 Pulse angiographic X-ray system recall status

Companies & origin

Recalling firm location: Waukesha, WI, United States
Firm address: 3000 N Grandview Blvd, N/A, 53188-1615

Identifying details (verbatim from the notice)

Product codes / lots: 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: Worldwide - US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98880
Recall initiated: April 20, 2026
FDA classified: June 5, 2026
FDA report date: June 17, 2026

Other medical device recalls from around the same time

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Design Options Spinal Tray Spinal Needle Anesthesia procedure kits recall — B Braun Medical IncFDA · June 10, 2026
Spinocan Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 2026
Spinal Needle procedure kits recall — B Braun Medical IncFDA · June 10, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 15, 2026 at 6:00 PM UTC.

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