Z-1306-2022Class II

NaviCare Nurse Call/Voalte Nurse Call

Name: Z-1306-2022 NaviCare Nurse Call/Voalte Nurse Call
Creator: Baxter Healthcare Corporation
Published: 2022-05-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-05-31 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of NaviCare Nurse Call/Voalte Nurse Call on 2022-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1306-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-31
Posted: 2022-06-30
Recalling firm: Baxter Healthcare Corporation
Product: NaviCare Nurse Call/Voalte Nurse Call
Product code: ILQ System, Communication, Powered
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm disseminated an Urgent Medical Device Correction Notice beginning on 05/31/2022 by letter. The letter described the problem and requested the following actions be taken by the customer: "Identify if your Nurse Call System utilizes one of the impacted wireless integrations identified. If so, please share the information with potential users in your organization. Hillrom recommends reviewing the wireless system settings with your wireless provider to determine if there are configurable options for call acceptance only. Complete the enclosed response form and return to [email protected] within two weeks of receipt of this notice, to confirm you have received this communication and understand the potential issue." Persons with questions were directed as follows: "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support, available twenty-four hours a day, seven days a week, at 1-800-445-3720, option 3, or [email protected]"
Quantity in commerce: 283 installations
Distribution: nationwide and Canada
Product codes and lots: software versions: 3.9.100, 3.9.101,3.9.102, 3.9.200, 3.9.201, and 3.9.300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1306-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1306-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code ILQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)