CLASS II Device recall · Reported 25 May 2022 · FDA Enforcement Report

Voalte Nurse Call System provides a comprehensive recalled

Baxter Healthcare is recalling Voalte Nurse Call System provides a comprehensive communication and information system, distributed in North Carolina, Virginia. The recall was initiated on 13 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesInternal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch

Quantity recalled1414 units

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-1094-2022
FDA event ID: 89961
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2022
FDA classified: 13 May 2022
Reported: 25 May 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Medical Software

Timeline

13 Apr 2022	Recall initiated by company
13 May 2022	Classified by FDA	+30 days
25 May 2022	Published in enforcement report	+12 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 a firmware memory leak with a supplier-manufactured component.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

Where it was distributed

US Distribution to states of: NC and VA.

North Carolina Virginia

Questions about this recall

Why was it recalled?

Firm discovered a firmware memory leak with a supplier-manufactured component.

Which lots are affected?

Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch

Where was it sold?

US Distribution to states of: NC and VA.

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

Other products in this recall event

1 other product · FDA event 89961

Reported	Class	Recall	Company	Reason	Where
25 May 2022	CLASS II	NaviCare Nurse Call System provides a comprehensive recalled	Baxter Healthcare	Packaging Defects	NC, VA

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