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U.S. Department of Health and Human Services

Class 2 Device Recall NaviCare Patient Safety Software

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  Class 2 Device Recall NaviCare Patient Safety Software see related information
Date Initiated by Firm February 14, 2020
Create Date March 22, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-1554-2020
Recall Event ID 85010
Product Classification Monitor, bed patient - Product Code KMI
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)
Code Information NaviCare Patient Safety Software versions 3.5.400 to 3.9.300
Recalling Firm/
Manufacturer		 Hill-Rom Inc.
1225 Crescent Grn Ste 300
Cary NC 27518-8119
For Additional Information Contact
1-800-445-3720 Ext. 3
Manufacturer 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 2		 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 in Commerce 35 Software Systems
Distribution Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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