Product Safety Recalls

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 89437

Description: Zenition 50, Model #718096

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall 89437 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0647-2022
Event ID89437
Event DescriptionZenition 50, Model #718096
Product TypeDevices
DistributionDomestic 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.
Quantity16 US; 76 ROW
Recall ReasonFirm 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.
Device Classification20220223
Device Code InfoWireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231
Center Classification Date20220217
Recall Initiation Date20211202
Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Initial Notification Letter
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