Recall Z-2315-2026 ยท OWB Interventional Fluoroscopic X-Ray System
GE Medical Systems, LLC
Allia IGS 5 Pulse angiographic X-ray system
| Date | Jun 5, 2026 (initiated Apr 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE CORRECTION dated 4/20/26 was sent to customers. Actions to be taken by Customer/User You can continue to use your system. As a reminder, qualified service personnel must follow the Service Manual applicable to your system and use the appropriate personal protective equipment (PPE) for electrical hazards when performing any activity inside the cabinet while power is ON. If any abnormal condition is observed on the Iris Power Cable during servicing, such as loose or visibly exposed wires, qualified service personnel must follow the Electrical Lockout/Tagout Procedure |
| Quantity | 121 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR GE Medical Systems SCS, Oct 11, 2023 |