Recall Z-1554-2020
Hill-Rom Inc. · initiated February 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: NaviCare Patient Safety Software versions 3.5.400 to 3.9.300
Reason for recall
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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).
Details
- Recall number
- Z-1554-2020
- Initiated
- February 14, 2020
- Terminated
- February 11, 2021
- Product code
- KMI – Monitor, Bed Patient
- Quantity
- 35 Software Systems
- Distribution
- Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
- Recalling firm
- Hill-Rom Inc., Cary, NC