Skip to content
Recall Observatory FDA recall evidence

Device product

Zenition 70, Model #718133

Z-0648-2022

December 02, 2021

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 89437
Status
Ongoing
Classification
Class II
Quantity
95 US; 284 ROW
Official record key
device-enforcement:Z-0648-2022

Official wording

Reason: 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.

Code information: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware issue