Recall Z-2315-2026
- Recall number
- Z-2315-2026
- Event number
- 98880
- Firm
- GE Medical Systems, LLC
- Firm FEI
- 2126677
- Product code
- OWB
- Status
- Open, Classified
- Initiated
- 2026-04-20
- Posted
- 2026-06-05
- Root cause
- Device Design
- 510(k) numbers
- K232344, K170800, K243646, K181966, K223409, K151000, K082243, K161976, K240224, K172180, K203281, K221344, K121772, K210055, K141574, K250241, K974355, K912448, K122457, K022322, K252500, K151598, K061203, K222625, K021049, K183109, K103425, K240199, K123529, K010435
Product#
Allia IGS 5 Pulse angiographic X-ray system
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.