Nurse Call Communication System Components May Fail to Reboot
Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard—a communication system component failing to reboot and becoming non-functional—represents a risk-of-harm product in a healthcare setting, though injury has not yet been reported.
Plain-English summary
Hill-Rom Inc. is recalling NaviCare Nurse Call systems (Part Numbers 3.6, 3.7, 3.9) and Voalte Nurse Call systems (Part Number 4.0), which are communication systems used in healthcare facilities. The affected product has been distributed worldwide, including throughout the United States, with approximately 1,050 units involved.
An unrecoverable software error may occur where a component fails to complete its reboot cycle, rendering the component non-functional and requiring replacement. This issue affects all software versions 3.5.400 and above.
Healthcare facilities using these systems should verify whether their equipment is affected by reviewing the provided part numbers and unit identifiers (UDI). Users experiencing component failures or reboot issues should contact Hill-Rom for replacement components or additional guidance.
The recalled product
- 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
- Manufacturer
- Hill-Rom Inc.
- Affected units
- 1,050
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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