FDA DevicesClass II
Allia IGS 5 Pulse angiographic X-ray system
Published: June 17, 2026Recall ID: Z-2315-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Allia IGS 5 Pulse angiographic X-ray system
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98880 |
| Address 1 | 3000 N Grandview Blvd |
| Address 2 | N/A |
| Code info | 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-... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 121 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260420 |
| Initial firm notification | Letter |
| Center classification date | 20260605 |
Overview
- Recalling FirmGE Medical Systems, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.