Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
FDA Recall Z-2176-2018 · Posted None
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2018-03-30
Date Terminated2020-04-14
Product Quantity20
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.