Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Date of Enforcement Report: 1/16/2026
Class: II

PRODUCT:

Recall Number:

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.

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

VOLUME:

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;