Z-0647-2022 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A

Recall Details

Product Type
Devices
Report Date
February 23, 2022
Initiation Date
December 2, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 US; 76 ROW

Product Description

Zenition 50, Model #718096

Reason for Recall

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.

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.

Code Information

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