Z-2322-2017 Class II Terminated
FDA device recall Z-2322-2017 was initiated by Philips Electronics North America Corporation on May 31, 2017 and is designated Class II. Reason for recall: Tube arm assembly could fall down due to cracked welding joints The recall status is terminated (terminated August 24, 2018). Affected quantity: 98 sytems.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 31, 2017
- Termination Date
- August 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 sytems
Product Description
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
Reason for Recall
Tube arm assembly could fall down due to cracked welding joints
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.
Code Information
SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002