These are communication systems, labeled as recallZ-0402-2022 · Hill-Rom Inc. · initiated Oct 14, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hill-Rom Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0402-2022
- Status
- Terminated
- Initiated by the company
- Oct 14, 2021
- Recalling firm
- Hill-Rom Inc.
- Quantity
- 1,050 units
- Product code
- ILQ
- Distribution
- Worldwide distribution - US Nationwide.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Voalte Nurse Call 4.0Hill-Rom, Inc. · System, communication, powered2 recalls2 deaths405 reports
- NaviCare® Nurse Call Systems 3.9Hill-Rom, Inc. · System, communication, powered2 recalls2 deaths87 reports
- NaviCare® Nurse Call Systems 3.6Hill-Rom, Inc. · System, communication, powered1 recall12 reports
- NaviCare® Nurse Call Systems 3.7Hill-Rom, Inc. · System, communication, powered1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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