Recall Z-0255-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, s
| Date | Dec 18, 2017 (initiated Aug 18, 2017) |
| Status | Terminated |
| Reason | When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination. |
| Root cause | Software design |
| Action | Image Guided Therapy Systems ( IGT) sent an Urgent - Field Safety Notice Medical Device Correction letter dated August 11. 2017. The Downscale option should be disabled in all Export protocols until Philips corrects this issue. To accomplish this, you may refer to Chapter 13.8 (Configuring Export Protocols) of the system instructions for use that describes how to perform this action. You may also contact your Philips local representative for assistance in performing this action. All archived images exported using the downscale option would be affected by this issue, therefore such measureme |
| Quantity | 157 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162148 | Allura Xper R9 Philips Medical Systems Nethrlands BV, Nov 23, 2016 |