Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27981
Brand Name:X-ray system, fluoroscopic, general-purpose, mobile, digital
Model:Coin Cell Battery depletion on OEC Elite systems manufactured on or after January 2019 and all OEC 3D mobile C-Arm systems.
Affected:
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:OEC Medical Systems Inc
Issue:The manufacturer has become aware of a potential issue related to certain OEC Elite and OEC 3D mobile C-Arms. Service record data has shown an increased replacement rate than previously observed of the coin cell battery used to monitor X-Ray tube temperature. When the coin cell battery voltage is depleted, the system will produce an error message and prevent further operation, which may occur during the initial boot up of the system, or during use of the system.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:5/7/2021
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /