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

Recall Z-1897-2016 — Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

U.S. FDA — Device Enforcement · United States · 2016-05-17 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1897-2016
Date of alert: 2016-05-17
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Carefusion 211 Inc dba Carefusion
Product category: device
Product type: Devices

Reported risk: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1897-2016 — Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

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