FDA DevicesClass II
Allia IGS 7 Pulse angiographic X-ray system
Published: June 17, 2026Recall ID: Z-2316-2026Category: 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 7 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: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007 |
| Postal code | 53188-1615 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 35 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.