Medical device recalls Moderate risk

Hill-Rom Inc. recalls These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call,…

Recall date
October 14, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0402-2022
FDA classification
Class II
Brand / firm
Hill-Rom Inc.
Sold / distributed
Worldwide distribution - US Nationwide.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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