Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-2176-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 30, 2018

Date Posted: June 20, 2018

Recall Number: Z-2176-2018

Event ID: 80094

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.

Status: Terminated

Product Quantity: 20

Code Information:

System Serial Numbers: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated