Device product
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)
Z-1554-2020
Product summary
- Firm
- Hill-Rom Inc.
- Event
- Event 85010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 Software Systems
- Official record key
device-enforcement:Z-1554-2020
Official wording
Reason: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Code information: NaviCare Patient Safety Software versions 3.5.400 to 3.9.300
Distribution pattern: Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Derived failure modes
-
Device software or design
software issue which may result in failure