PlainRecalls
FDA Devices Moderate Class II Ongoing

Veradius Unity, Model #718132

Reported: February 23, 2022 Initiated: December 2, 2021 #Z-0649-2022

Product Description

Veradius Unity, Model #718132

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.

Details

Units Affected
12 US; 44 ROW
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.
Location
Best, N/A

Frequently Asked Questions

What product was recalled?
Veradius Unity, Model #718132. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 12 US; 44 ROW.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 23, 2022. Severity: Moderate. Recall number: Z-0649-2022.