Z-2007-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- May 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 software versions
Product Description
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
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 Pattern
US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
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