Z-1251-2015Class II

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

Name: Z-1251-2015 Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Creator: Philips Medical Systems, Inc.
Published: 2015-01-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-01-23 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211 on 2015-01-23. FDA classified it as Class II and gives the reason as "Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1251-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Posted: 2015-03-06
Terminated: 2016-06-07
Recalling firm: Philips North America LLC
Product: Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 71 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code KPR

K141381Class IIDuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. / cleared 2014-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)