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Recall Observatory FDA recall evidence

Device product

Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)

Z-2322-2017

May 31, 2017

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 77410
Status
Terminated
Classification
Class II
Quantity
98 sytems
Official record key
device-enforcement:Z-2322-2017

Official wording

Reason: Tube arm assembly could fall down due to cracked welding joints

Code information: SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tube arm assembly could fall down due to cracked welding joints