Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
This recall is currently active, issued June 26, 2023. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- May 19, 2023
- Posted
- June 26, 2023
- Recall Number
- Z-2006-2023
- Quantity
- 8 software versions
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Lot / Code Info
UDI/DI 00887761995086, Software Versions: 4.0: 4.0.000, 4.0.100, 4.0.110, 4.0.200, 4.0.300, 4.0.301, 4.0.400, 4.0.401
Root Cause
Device Design
Action Taken
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.