Recall Z-2322-2017 ยท KPR System, X-Ray, Stationary
Philips Electronics North America Corporation
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
| Date | May 31, 2017 |
| Status | Terminated |
| Reason | Tube arm assembly could fall down due to cracked welding joints |
| 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 | 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, Egyp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141381 | DURADIAGNOST Philips Healthcare (Suzhou) Co., Ltd., Jun 12, 2014 |