FDAFDA · Food and drugs·Recall number Z-0402-2022
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
Published December 29, 2021 · Recall initiated: October 14, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Hill-Rom Inc.
- Distributor
- Worldwide distribution - US Nationwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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