Philips Azurion system; Software Version Number: R3.1;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 12, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Country / region | Netherlands 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; |
Hazard
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.
Affected products
- Philips Azurion system; Software Version Number: R3.1;
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