- Recalling firm
- GE Medical Systems, LLC
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00198953052488; Serial Numbers: C4-25-001, C4-25-002, C4-26-001, C4-26-002, C4-26-004, C4-26-005
- Units affected
- 3 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Waukesha, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2318-2026
- Recall initiated
- April 20, 2026
- FDA classification date
- June 5, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98880
- Last updated on HTM Vibe
- July 23, 2026