Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2111-2016)

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 CT Big Bore Oncology, model #728243; 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-2111-2016

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 and cause injury to patients, operators, by standers or service personnel.

Status: Terminated

Product Quantity: 3 units

Code Information:

921216

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated