FDAFDA · Food and drugs·Recall number Z-0647-2022
Zenition 50, Model #718096
Published February 23, 2022 · Recall initiated: December 2, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
- Lot
- Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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