medical Class II Updated 2018-06-20

Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741

Recalled Product

Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. 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: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424
View official government recall

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