Recall Z-1113-2026 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion system; Software Version Number: R3.1;
| Date | Jan 16, 2026 (initiated Dec 12, 2025) |
| Status | Open, Classified |
| Reason | Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand. |
| Root cause | Software design |
| Action | On December 12, 2025, Philips sent URGENT Medical Device Correction letters to customers. Actions to be taken: - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issues. " In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your sys |
| Quantity | 228 units (all OUS) |
| Distribution | International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA; |
| 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 |