medical Class II Updated 2018-06-20

Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351,

Recalled Product

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system


Hazard / Issue

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.

Issued by

FDA

Affected States: CA, MD, NV, OH, TX, WI
Lot/Code Info: System Serial Numbers: 10605, 10708, 9208
View official government recall

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