FDA-Device2022-02-23Class II
Zenition 50, Model #718096
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Sold states
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.
Affected count
16 US; 76 ROW
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Zenition 50, Model #718096
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0647-2022Don't want to check this manually?
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