CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

NaviCare Nurse Call/Voalte Nurse Call recalled by Baxter Healthcare

Baxter Healthcare is recalling NaviCare Nurse Call/Voalte Nurse Call, distributed nationwide in the US. The recall was initiated on 31 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codessoftware versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300

Quantity recalled283 installations

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-1306-2022
FDA event ID: 90322
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 31 May 2022
FDA classified: 30 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 May 2022	Recall initiated by company
30 Jun 2022	Classified by FDA	+30 days
6 Jul 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

An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

NaviCare Nurse Call/Voalte Nurse Call

Where it was distributed

nationwide and Canada

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300

Where was it sold?

nationwide and Canada

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.

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