FDA recall Z-1306-2022

Baxter Healthcare Corporation · Class II · device

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.

Distribution

nationwide and Canada

Key facts

Status
Ongoing
Initiation date
2022-05-31
Report date
2022-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2022