Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2113-2016)

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 Flex, model # 728317; 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-2113-2016

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: 10 units

Code Information:

901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, 901541

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated