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Recall Observatory FDA recall evidence

Device product

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,

Z-0812-2018

June 30, 2017

Class II

Product summary

Firm
ZOLL Medical Corporation
Event
Event 79248
Status
Terminated
Classification
Class II
Quantity
46
Official record key
device-enforcement:Z-0812-2018

Official wording

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

Code information: Models EMV+, AEV, Eagle II,and Eagle II MRI

Distribution pattern: Outside US

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly