Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-2110-2016)

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:

Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Product Classification:

Class II

Date Initiated: June 14, 2016

Date Posted: July 6, 2016

Recall Number: Z-2110-2016

Event ID: 74507

Reason for Recall:

Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.

Status: Terminated

Product Quantity: 89

Code Information:

Big Bore Radiology System Code 728244; Serial numbers 75033, 75110

Distribution Pattern:

Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated