CLASS II ONGOING Device recall · Reported 23 Feb 2022 · FDA Enforcement Report

Veradius Unity recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling Veradius Unity, distributed in 23 states. The recall was initiated on 2 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesWireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Quantity recalled12 US; 44 ROW

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0649-2022
FDA event ID: 89437
Recalling firm: Philips Medical Systems Nederland B.v, Best, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 2 Dec 2021
FDA classified: 17 Feb 2022
Reported: 23 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Dec 2021	Recall initiated by company
17 Feb 2022	Classified by FDA	+77 days
23 Feb 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Veradius Unity, Model #718132

Where it was distributed

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.

Arizona California Florida Georgia Illinois Kansas Kentucky Massachusetts Maryland Michigan Minnesota Mississippi North Carolina Nebraska New Jersey Nevada New York Pennsylvania Tennessee Texas

Questions about this recall

Is Veradius Unity recalled?

Yes. Philips Medical Systems Nederland B.v recalled Veradius Unity on 2 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0649-2022.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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