Recall Z-1344-2026— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-1344-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-26

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2026-01-26. It names 3 FDA 510(k) clearances: K200917, K181830, K172822. Product: Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X. Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2026-01-26
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

3 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01
K181830 — Azurion R2.0Philips Medical Systems Nederland B.V.·cleared 2018-08-02
K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V.·cleared 2017-11-22

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

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

Reason for recall

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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