Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00499-1
Product Name/Description GE Healthcare Revolution EVO & Optima CT Systems

CT660, CT670, CT680, CT540

Revolution EVO
Model Numbers: 5454001-61, 5454001-160, 5454001-60 and 5454001-260

Optima CT660
Model Numbers: 5454001, 5454001-41, -100, -220, -200, -40, -22, -140, -240, -122, -222

Optima CT670/680
Model Numbers: 5454001-230, 5454001-330

Optima CT540
Model Numbers: 5432539, 5432539-2, 5432539-3, 5432539-5 and 6447929

ARTG Number: 116979
Recall Action Level Retail
Recall Action Classification Class I
Recall Action Commencement Date 16/05/2018
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. This issue does not affect patients or operators external to the equipment.

When the gantry front cover is removed to allow servicing of components inside the gantry, cover dollies are used to manipulate the cover. During the removal or reattachment of the front cover, a bracket can contact an internal power supply cable and damage that cable’s insulation. This can expose the conductor of a 120VAC power supply cable and electrify the cover dolly, thereby introducing the risk of an electrical shock hazard to the Service Personnel.
Recall Action Product Defect Correction
Recall Action Instructions GE Healthcare is advising they will be in contact with affected users to arrange for the correction to be implemented.
In the interim, the system may continue to be used as this issue does not impact patients or CT operators. Users should ensure service technicians are aware of the issue and to wear protective gloves when using the cover dollies.
GE Healthcare have updated the service manual to prevent recurrence of this issue in the event of a replacement of the cable in the future. Users should follow the instructions outlined on the Customer Letter to download the latest Service Manual.

This action has been closed out on 26/02/2019
Contact Information 1800 659 465 - GE National Call Centre