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Philips Medical Systems (Cleveland) Inc recalls Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole bod
Recalled July 6, 2016 · FDA recall Z-2110-2016 · 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
89
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 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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →