Recall Z-2316-2026

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.

FDA-determined cause: Device Design

Action taken

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 as described in Service Manual. Please ensure that all potential users and service personnel in your facility are made aware of this safety notification and the recommended actions and post this letter in a visible location near the C-FRT cabinet. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 18014 Digital Response Form or print, fill out manually, scan, and email to recall.18014@gehealthcare.com.