FDA Medical Device Recalls (openFDA)
Hill-Rom Inc.: 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)
- Recall number
- Z-1554-2020
- Recalling firm
- Hill-Rom Inc.
- 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)
- Status
- Terminated
- Initiated
- 2020-02-14
- Posted
- not on file
- Terminated
- 2021-02-11
- Reason
- There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- The firm issued a Urgent Medical Device notification on 02/14/2020 by letter. The letter identified the reason and requested the following actions be taken: 1. Hillrom is recommending customers disable the NPS software module, including monitoring for Bed Exit Not Armed, to avoid the potential for staff being unaware of the bed exit state. 2. With the NPS software disabled, caregivers will need to return to manually arming the bed exit to alert for patients exiting the bed. Hillrom is developing a software update for NaviCare Patient Safety and anticipates availability in April 2020. Next Steps: Hillrom will be reaching out to assist you with disabling the software module and plan your upgrade. If you have any questions, or would like to proactively schedule an upgrade, please contact Hillrom Technical Support at 1-800-445-3720, option 3 (Cary), option 1 (NaviCare Nurse Call).
- Quantity
- 35 Software Systems
- Distribution
- Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
- Lot, serial or model codes
- NaviCare Patient Safety Software versions 3.5.400 to 3.9.300
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMI
- Firm FEI
- 2027454
- Firm city
- Cary
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28