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Recall Observatory FDA recall evidence

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

February 14, 2020

Class II

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

    reason.device_software_design · v1.0.0

    software issue which may result in failure