Recall Z-2403-2023— Philips Medical Systems Nederland B.V.

Name: FDA recall Z-2403-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-19

Class II · Ongoing

Class II FDA medical device recall by Philips Medical Systems Nederland B.V., initiated 2023-07-19. It names 3 FDA 510(k) clearances: K200917, K181830, K172822. Product: Azurion. Reason: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

Recalling firm: Philips Medical Systems Nederland B.V.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-19
Firm location: Eindhoven, 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

Reason for recall

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

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