Device Recall Philips Healthcare Brilliance 16 의 리콜

Recall

80094

Class 2

Z-2175-2018

2018-03-30

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164548

The patient support head holder could contact the back iso shelter wall during manual or motorized motion through the gantry bore. this may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

Urgent Field Safety Notices dated 3/28/18 were distributed to customers. The letters instructed customers to perform the following actions: Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. As outlined in the Instructions for Use, always monitor the patient during all movements (manual or motorized) of the patient support. If you recognize an impending collision with the back shelter wall, halt the motion or activate the system E-stop. Mandatory Field Change Order (FCO) 72800686 which will add additional warning labels specific to this issue to the system. The FCO will be implemented free of charge.