Recall Z-1554-2020— Hill-Rom Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom Inc., initiated 2020-02-14, terminated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. 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: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism..
- Recalling firm
- Hill-Rom Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-14
- Terminated
- 2021-02-11
- Firm location
- Cary, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.