Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19753
Brand Name:3.0T GEMflex Coil from NeoCoil
Model:5430008-2, 5430008-3, 5430008-4 and 5430008-5
Affected:
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:NeoCoil LLC
Issue:Manufacturer has advised that part of the cable assembly may overheat when the device is used. Rarely, this could result in minor burn injury in case of prolonged direct skin contact with the overheating part.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:12/2/2016
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