FDA-Device2021-12-29Class II
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
Hill-Rom Inc.
Hazard
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
Sold states
Worldwide distribution - US Nationwide.
Affected count
1,050 units
Manufactured in
1225 Crescent Grn Ste 300, N/A, Cary, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2022Don't want to check this manually?
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