FDAClass IIJuly 6, 2022

NaviCare Nurse Call/Voalte Nurse Call recall: Software Issue

NaviCare Nurse Call/Voalte Nurse Call

Why was NaviCare Nurse Call/Voalte Nurse Call recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
NaviCare Nurse Call/Voalte Nurse Call
Recalling firm
Baxter Healthcare Corporation
Quantity
283 installations
Distribution
nationwide and Canada
Recall date
July 6, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls