Data Foundry

Medical device recalls 2022

NaviCare Nurse Call/Voalte Nurse Call — Class II medical device recall Z-1306-2022

Ongoing recall by Baxter Healthcare Corporation, reported 2022-07-06, distributed nationwide. An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wirele

Recall numberZ-1306-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2022-05-31
Classified2022-06-30
Reported by FDA2022-07-06
DistributedNationwide (US)
Countries outside the USCA
Quantity283 installations
Reason classessoftware

Product

NaviCare Nurse Call/Voalte Nurse Call

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1306-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.