Z-2322-2017Class II

Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product...

Name: Z-2322-2017 Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product...
Creator: Philips Electronics North America Corporation
Published: 2017-05-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-05-31 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number... on 2017-05-31. FDA classified it as Class II and gives the reason as "Tube arm assembly could fall down due to cracked welding joints". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2322-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Posted: 2017-06-09
Terminated: 2018-08-24
Recalling firm: Philips North America LLC
Product: Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Product code: KPR System, X-Ray, Stationary
Reason for recall: Tube arm assembly could fall down due to cracked welding joints
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated May 23, 2017, advising users of the problem and asking facilities to stop using the device until a Philips Engineer can go on-site to perform the FC071200173; contact your local Philips representative if you have any concern or support required on this issue. If you need any further information or support concerning this issue, contact your local Philips representative. For further questions, please call (978) 659-3000.
Quantity in commerce: 98 sytems
Distribution: Worldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany, Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina, Chile, Colombia, Egypt, United Arab Emirates, Saudi Arabia, Hungary, Peru, Poland, Indonesia, Burkina Faso, Kazakhstan, Turkey and Slovenia.
Product codes and lots: SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2322-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2322-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-09

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)