Philips Azurion system; Software Version Number: R3.1;
Reported: January 28, 2026 Initiated: December 12, 2025 #Z-1113-2026
Product Description
Philips Azurion system; Software Version Number: R3.1;
Reason for Recall
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.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 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;
- Location
- Best
Frequently Asked Questions
What product was recalled? ▼
Philips Azurion system; Software Version Number: R3.1;. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 228 units (all OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1113-2026.
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