—#147899

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: Big Bore Radiology System Code 728244; Serial numbers 75033, 75110

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Philips Medical Systems (Cleveland), Inc. sent a Customer Information letter dated June 14, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. No action is required of the customer for this issue. Systems that may have been manufactured with these stainless steel fasteners still meet the safety specifications required for the adjustment cradle and may continue to be used clinically. For further information or support customers were instructed to call 1-800-722-9377. For questions regarding this recall call 404-483-2015.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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

Timeline

Recall initiated: 2016-06-14
Terminated: 2018-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.