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

Recall Z-0827-2016 — Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

U.S. FDA — Device Enforcement · United States · 2016-02-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0827-2016
Date of alert
2016-02-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Draeger Medical, Inc.
Product category
device
Product type
Devices
Reported risk: The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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