Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
This recall has been terminated (originally issued March 30, 2018).
- Recall Initiated
- March 30, 2018
- Terminated
- April 14, 2020
- Recall Number
- Z-2174-2018
- Quantity
- 3
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
Lot / Code Info
System Serial Numbers: 10605, 10708, 9208
Root Cause
Device Design
Action Taken
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.