Recall Z-2174-2018 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 shelt |
| Quantity | 3 |
| Distribution | Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |