Recall Z-2932-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
| Date | Aug 10, 2026 (initiated Jul 16, 2026) |
| Status | Open, Classified |
| Reason | Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications. |
| Root cause | Software design |
| Action | Philips issued an URGENT Medical Device Correction to its consignees on 7/16/2026 via certified mailing. The notice explained the issues, potential harms associated with the issues, and provide instructions for the safe operations of the device pending a software update. The instructions are as follows: Issue 1: Image quality degradation If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions for Use: o On the Review Module, press and hold Power Off . o Release the button when the |
| Quantity | 2016 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |