Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2112-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

Product Classification:

Class II

Date Initiated: June 21, 2016

Date Posted: July 6, 2016

Recall Number: Z-2112-2016

Event ID: 74511

Reason for Recall:

Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.

Status: Terminated

Product Quantity: 1 unit

Code Information:

911162

Distribution Pattern:

Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated