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
Product summary
- 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
Tube arm assembly could fall down due to cracked welding joints