Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2114-2016)

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:

Ingenuity Core 128, model #728323; 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-2114-2016

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 causing injury to patients, operators, by-standers and service personnel.

Status: Terminated

Product Quantity: 14 units

Code Information:

901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated