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[Recalled] Zenition 50, Model #718096 — Firm discovered that the wireless foot switch can suddenly stop responding due… | FDA 2021-12-02

recall fda device netherlands

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductZenition 50, Model #718096
Brand / manufacturerPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0647-2022
Country of noticeNetherlands
Risk levelClass II
Hazard typerecall
Notice date02 December 2021
EAN / barcode459801238191

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in Netherlands and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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