Fresh Recalls

Allia IGS 5 Pulse angiographic X-ray system: recall status

Notice names this product. GE Medical Systems’s Allia IGS 5 Pulse angiographic X-ray system is named in FDA Class II recall Z-2315-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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. Units affected: 121 units. Status: Ongoing.

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 5 Pulse angiographic X-ray system
Company / brand
GE Medical Systems
Lot / serial / date codes
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
Distribution
Worldwide - US Nationwide distribution.
Agency product description and boundaries

Allia IGS 5 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.

Brand
GE Medical Systems

Recalls naming this model

FDA Class II · Medical device · June 17, 2026

Allia IGS 5 Pulse angiographic X-ray system recall — GE Medical Systems, LLC

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 electrica…

Company / brand: GE Medical Systems recalls

Affected product: Allia IGS 5 Pulse angiographic X-ray system recall status

Official ID Z-2315-2026 · Official record ↗

See all GE Medical Systems recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.