TruVidia Wireless Receiver 의 리콜

Recall

RC-2018-RN-00075-1

Class II

2018-01-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00075-1

Trumpf medical discovered that the radiated emission from the truvidia wireless receiver is above the normative accepted limits. it is unlikely, but possible, that the radiated emission may interact with other devices in the operating room, which may cause other devices to not function properly. the frequency of interference and associated risk will be dependent upon the immunity of the other devices for radiated emissions and nature of the failure mode of the operating room equipment being used at the time.

Trumpf Medical is advising users that an upgrade of the affected components will be completed as a permanent correction. If users suspect that the device may be interacting with other devices in the operating room, switch off the wireless receiver (ensure the receiver is switched off, it is not sufficient to switch off the camera or control unit).