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

Recalling company

GE Medical Systems, LLC

Product

Allia IGS 5 Pulse angiographic X-ray system

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 20, 2026

Reported

Jun 17, 2026

Distribution

Worldwide - US Nationwide distribution.

Status

Ongoing

Quantity

121 units

Lot / 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, M3-25-14

Company location

Waukesha, WI

Recall type

Voluntary: Firm initiated

Recall number

Z-2315-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2315-2026 in the FDA Enforcement Report. Also see FDA recall press releases.