Recall Z-2404-2023— Philips Medical Systems Nederland B.V.

Name: FDA recall Z-2404-2023
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 2 FDA 510(k) clearances: K050151, K023441. Product: MultiDiagnost-Eleva. 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

2 on FDA's record

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09
K023441 — PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems·cleared 2002-10-30

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

MultiDiagnost-Eleva

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.