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Recall Observatory FDA recall evidence

Device product

NaviCare Nurse Call/Voalte Nurse Call

Z-1306-2022

May 31, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90322
Status
Ongoing
Classification
Class II
Quantity
283 installations
Official record key
device-enforcement:Z-1306-2022

Official wording

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.

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

Distribution pattern: nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.