FDA Enforcement
Class II
Terminated
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.
Recall: Z-2110-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2110-2016
- Event ID
- 74507
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 6, 2016
- Initiation Date
- June 14, 2016
- Classification Date
- June 30, 2016
- Termination Date
- July 2, 2018
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131, United States
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.
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 Info
Big Bore Radiology System Code 728244; Serial numbers 75033, 75110
Distribution
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
Quantity
89