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Recall Observatory FDA recall evidence

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

June 14, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
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

    reason.no_named_rule · v1.0.0

    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.