TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Allia IGS 7 Pulse angiographic X-ray system
Check your package for
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
- Why
- 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.
- Distributed
- Worldwide - US Nationwide distribution.
- Company
- GE Medical Systems, LLC
- Announced
- Recall began