Recall Z-1130-2019 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America, LLC
Azurion FlexArm, 722079
| Date | Mar 12, 2019 |
| Status | Terminated |
| Reason | During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector. |
| Root cause | Component design/selection |
| Action | On March 12, 2019, the firm distributed Urgent Medical Device Correction letters to affected consignees, alerting customers that the cable set in the C-arc of the Azurion R2.0 was not according to specifications, which resulted in damage of the 24V power cable of the detector. Customers were asked to place a copy of the field safety notice together with the documentation of the system until the system is inspected and corrected (if applicable) by Philips. The firm will inspect the affected systems free of charge and correct as necessary. If you need any further information or support concer |
| Quantity | 2 |
| Distribution | Distributed to one account in Florida, and one international account in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181830 | Azurion R2.0 Philips Medical Systems Nederland B.V., Aug 2, 2018 |