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)
FDA Recall Z-1554-2020 · Posted None
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Recalling FirmHill-Rom Inc.
Recall StatusTerminated
Product CodeKMI
Date Initiated2020-02-14
Date Terminated2021-02-11
Product Quantity35 Software Systems
Reason for Recall
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Firm 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).
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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