| Class 2 Device Recall Voalte Patient Safety (previously branded as NaviCare) | |
Date Initiated by Firm | May 19, 2023 |
Date Posted | June 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2007-2023 |
Recall Event ID |
92300 |
Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
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Product | NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed |
Code Information |
UDI/DI 00887761985193, Software Versions: 3.9: 3.9.200,3.9.201, 3.9.300, 3.9.400, 3.9.401, 3.9.500, 3.9.600 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield IL 60015-4625
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For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off. |
FDA Determined Cause 2 | Device Design |
Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/19/2023 by letter (USPS). The notice explained the issue, hazard, and requested the following:
Baxter is asking that you take the following actions:
1. Share this letter with your IT department (or other relevant personnel) to determine if you have the impacted software version and contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week, to schedule a software upgrade which addresses the identified issue.
2. You may continue to use your Voalte Patient Safety Software (VPS) (with your Centrella bed) until a software upgrade is completed by implementing either of these options into your clinical bedside workflow:
Option 1: When working with a patient in the room, and a bed exit alarm is activated, only silence the bed, and extend the silence timer instead of turning off bed exit.
" At the Graphical Room Station (GRS), click Menu
" Click Manage Bed
" On the Manage Bed screen, click the Safety Alerts ON / OFF slider button and the Delay button will pop up. Extend the silence period for the desired amount of time.
Option 2: After working with a patient in the room, and prior to exiting the room, enable Patient Safety at the Graphical Room Station (GRS).
" At the Graphical Room Station, click Menu
" Click Manage Bed on the Manage Bed screen, toggle the Safety Alerts button to ON .
For general questions regarding this communication, contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week.
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Quantity in Commerce | 7 software versions |
Distribution | US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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