NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Summary
The FDA issued a Class II for NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed by Baxter Healthcare Corporation. Reason: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. .
Details
Source
Device Recall
External ID
Z-2007-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Lot/Code Info: 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
Quantity Affected: 7 software versions
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-19
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2007-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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