—#133671

Product

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

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141381
Affected lot / code info: Serial Numbers: SN120001 SN120002 SN120003 SN130001 SN130002 SN130004 SN130005 SN130015 SN130019 SN130021 SN130003 SN130006 SN130007 SN130009 SN130010 SN130011 SN130012 SN130013 SN130014 SN130016 SN130017 SN130018 SN130020 SN130022 SN130023 SN140001 SN130001 SN130002 SN140001 SN140004 SN140005 SN140008 SN140009 SN140010 SN140012 SN140013 SN140019 SN140020 SN140021 SN140022 SN140024 SN140027 SN140033 SN140034 SN140036 SN140053 SN140062 SN130003 SN140002 SN140003 SN140006 SN140007 SN140016 SN140017 SN140018 SN140031 SN140035 SN140037 SN140039 SN140040 SN140041 SN140044 SN140045 SN140046 SN140048 SN140050 SN140051 SN140052 SN140056 SN140058 SN140060

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2015-01-23
Posted by FDA: 2015-03-06
Terminated: 2016-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133671. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.