Philips Medical Systems (Cleveland) Inc recalls Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body

Recalled July 6, 2016 · FDA recall Z-2109-2016 · Philips Medical Systems (Cleveland)

Hazard

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. · FDA Class II

Units

47 units

Sold at

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

Description

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.

Product

Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology 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

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →