Medical device recalls Moderate risk

Hill-Rom Inc. recalls NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is com…

Recall date
February 14, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1554-2020
FDA classification
Class II
Brand / firm
Hill-Rom Inc.
Sold / distributed
Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.

Why it was recalled

There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

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

What was recalled

NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

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