Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0647-2022 — Zenition 50, Model #718096

U.S. FDA — Device Enforcement · Netherlands · 2021-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0647-2022
Date of alert
2021-12-02
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
459801238191
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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