GE Healthcare Revolution EVO & Optima CT Systems CT660, CT670, CT680, CT540 의 리콜

Recall

RC-2018-RN-00499-1

Class I

2018-05-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00499-1

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.

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.