Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
FDA Recall Z-2322-2017 · Posted None
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Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeKPR
Date Initiated2017-05-31
Date Terminated2018-08-24
Product Quantity98 sytems
Reason for Recall
Tube arm assembly could fall down due to cracked welding joints
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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