—#148333

Product

UroDiagnost; x-ray system. Product Code: 708033

FDA product code: IXR — Table, Radiographic, Tilting
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K911098
Affected lot / code info: All serial numbers. 708033 System serial numbers 1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.

Why it was recalled

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

Root cause (FDA determination)

Device Design

Action the firm took

On July 19, 2016, Philips sent a Field Safety Notice to all affected customers. Philips Field Service Engineers will add an independent safety catch free of charge.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2016-07-19
Terminated: 2020-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148333. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.