CLASS II Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
These are communication systems, labeled as recalled by Hill-Rom
Hill-Rom is recalling These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, distributed nationwide in the US. The recall was initiated on 14 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0402-2022
- FDA event ID
- 88909
- Recalling firm
- Hill-Rom, Cary, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2021
- FDA classified
- 20 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2021 | Recall initiated by company | |
| 20 Dec 2021 | Classified by FDA | +67 days |
| 29 Dec 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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