Recall Z-1113-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1113-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2025-12-12. It names one FDA 510(k) clearance: K200917. Product: Philips Azurion system; Software Version Number: R3.1;. 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: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-12
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.