Recall Z-0648-2022— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-0648-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-02

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2021-12-02. It names one FDA 510(k) clearance: K183040. Product: Zenition 70, Model #718133. Reason: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-02
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K183040 — Zenition 70Philips Medical Systems Nederland B.V.·cleared 2018-12-06

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

Zenition 70, Model #718133

Reason for recall

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

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