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Terminated

Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211

FDA Recall Z-1251-2015 · Posted 2015-03-06

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2015-01-23
Date Terminated2016-06-07
Product Quantity71 units

Reason for Recall

Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

Firm Action

Philips Healthcare issued notice to foreign Distributors on 1/23/15 to issue and advise customers to stop using the device until a Philips Engineer checks the device. After the engineer verifies that the tube arm, Wall stand and table were properly assembled, the device may be used again. Philips will subsequently install a new Tube Arm and Wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future. Philips will subsequently provide the method to adjust the T-nuts of table to make sure it was properly assembled. A Philips Service Engineer will contact affected customers to install the solution.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan.

Official Source

View FDA Recall →

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

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