FDA recall Z-1554-2020

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)

Reason for recall

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

Distribution

Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.

Key facts

Status

Terminated

Initiation date

2020-02-14

Report date

2020-04-01

Termination date

2021-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1554-2020