Terminated

UroDiagnost; x-ray system. Product Code: 708033

FDA Recall Z-2306-2016 · Posted None

Recalling FirmPhilips Electronics North America Corporation

Recall StatusTerminated

Product CodeIXR

Date Initiated2016-07-19

Date Terminated2020-10-08

Product Quantity993 total

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911098PHILIPS URO DIAGNOST MRFPhilips Medical Systems, Inc. · 1991-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.