ZOLL Medical Corporation recalls 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in th…

Recall date

June 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0812-2018

FDA classification

Class II

Brand / firm

ZOLL Medical Corporation

Sold / distributed

Outside US

Why it was recalled

A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+¿ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,