Z-0812-2018Class II

731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for...

Name: Z-0812-2018 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for...
Creator: ZOLL Medical Corporation
Published: 2017-06-30
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2017-06-30 / Terminated / root cause: software

FDA source

ZOLL Medical Corporation began a recall of 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... on 2017-06-30. FDA classified it as Class II and gives the reason as "A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0812-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Posted: 2018-03-01
Terminated: 2018-10-09
Recalling firm: ZOLL Medical Corporation
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,
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On June 30, 2017 an urgent recall letter was mailed to customers with the following instructions: Customers who have affected devices should immediately take the following steps: (1) Alert all users of 731 Ventilator models to this problem. (2) Direct users to always verify device parameters after selecting the device Confirm button. (3) Contact ZOLL's Technical Service Department or your local ZOLL Service Provider to schedule a software update for affected devices Our 24/7 technical support numbers 1(800) 348-9011 or +l (978) 421- 9460 are available to assist users with any aspect of this notice.
Quantity in commerce: 46
Distribution: Outside US
Product codes and lots: Models EMV+, AEV, Eagle II,and Eagle II MRI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0812-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)