FDA DevicesClass II
Allia IGS Pulse angiographic X-ray system
Published: June 17, 2026Recall ID: Z-2317-2026Category: 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 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: 00195278827647; Serial Numbers: DVMSS2500001HL, DVMSS2500002HL, DVMSS2500003HL, DVMSS2500004HL, DVMSS2500005HL, DVMSS2500006HL, DVMSS2600001HL, DVMSS2600002HL |
| Postal code | 53188-1615 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 5 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.