—#164549

Product

Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: System Serial Numbers: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.

Timeline

Recall initiated: 2018-03-30
Terminated: 2020-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.