Z-1306-2022 Class II Ongoing
FDA device recall Z-1306-2022 was initiated by Baxter Healthcare Corporation on May 31, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 283 installations.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2022
- Initiation Date
- May 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 283 installations
Product Description
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 Pattern
nationwide and Canada
Code Information
software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1306-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026