Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2007-2023 — NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed

U.S. FDA — Device Enforcement · United States · 2023-05-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2007-2023
Date of alert
2023-05-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00887761985193
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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