PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system; Software Version Number: R3.1;

Recall date

December 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1113-2026

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

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;

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Azurion system; Software Version Number: R3.1;