Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00176-1
Product Name/Description 3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)

Affected Products:
3.0T GEM Flex Coil 16-L Array 5430008-2
3.0T GEM Flex Coil 16-M Array 5430008-3
3.0T GEM Flex Coil 16-S Array 5430008-4
3.0T GEM Flex Interface 5430008-5

ARTG Number: 153134
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 15/02/2016
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue GE Healthcare has recently become aware of a potential safety issue with the 3.0T GEMflex Coil manufactured by NeoCoil used with GE Healthcare 3.0T Scanners. Part of the cable assembly may overheat when the device is used. There is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. So far there have been no injuries reported as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. This action has been closed-out on 23/05/2017.
Contact Information 1800 659 465 - GE National Call Centre