Device 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.
Z-2110-2016
Product summary
- Event
- Event 74507
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89
- Official record key
device-enforcement:Z-2110-2016
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.