FDA-Device2020-04-01Class II
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)
Hill-Rom Inc.
Hazard
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Sold states
Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Affected count
35 Software Systems
Manufactured in
1225 Crescent Grn Ste 300, N/A, Cary, NC, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1554-2020Don't want to check this manually?
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