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

Recall Z-2064-2016 — Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

U.S. FDA — Device Enforcement · United States · 2016-05-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2064-2016
Date of alert
2016-05-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14566816
Reported risk: A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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