FDA recall Z-0648-2022

Product

Zenition 70, Model #718133

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

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.

Key facts

Status

Ongoing

Initiation date

2021-12-02

Report date

2022-02-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Best, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0648-2022