PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Medical Device Recall in 2022 - (Recall #: Z-0647-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Zenition 50, Model #718096

Product Classification:

Class II

Date Initiated: December 2, 2021

Date Posted: February 23, 2022

Recall Number: Z-0647-2022

Event ID: 89437

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.

Status: Ongoing

Product Quantity: 16 US; 76 ROW

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.

Voluntary or Mandated:

Voluntary: Firm initiated