Z-0402-2022Class II

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte...

Name: Z-0402-2022 These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte...
Creator: Hill-Rom Inc.
Published: 2021-10-14
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2021-10-14 / Terminated

FDA source

Hill-Rom Inc. began a recall of These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded... on 2021-10-14. FDA classified it as Class II and gives the reason as "An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0402-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-14
Posted: 2021-12-20
Terminated: 2024-08-16
Recalling firm: Hill-Rom Inc.
Product: These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
Product code: ILQ System, Communication, Powered
Reason for recall: An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
FDA root cause: Under Investigation by firm
Action: The firm disseminated a Medical Device Correction Notice to its consignees on 10/21/2021 by mail. Customer: Please share the information with potential users in your organization. Complete the attached response form and return to [email protected] within one month of receipt of this notice to confirm you have received this communication and understand the potential issue. In the event, this issue should occur please contact Hillrom Technical Support at 1-800-445-3720, option 3 or [email protected] for service and replacement. Hillrom has remediated this issue as part of the next software upgrade to version 4.0.300. Please contact Hillrom to discuss software upgrade. Distributor: Please share this information with your nurse call customer base. Complete the attached response form and return to [email protected] within one month of receipt of this notice to confirm you have received this communication, understand the potential issue and will take action to inform your customer base.
Quantity in commerce: 1,050 units
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: All software versions 3.5.400 and above: a. Part Number 3.6, UDI 00887761001541; Part Number 3.7, UDI 00887761021198; Part Number 3.9, UDI 00887761985209 b. Part Number 4.0, UDI 00887761995079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0402-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-20

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)