FDA Device recall Z-1306-2022
NaviCare Nurse Call/Voalte Nurse Call
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of NaviCare Nurse Call/Voalte Nurse Call by Baxter Healthcare, citing an issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1306-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-31 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
NaviCare Nurse Call/Voalte Nurse Call
Reason
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.
Identifiers
| code_info | software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1306-2022%22
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