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
Hazard
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
What You Should Do
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.
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Products
- UPC
- Models EMV+, AEV, Eagle II,and Eagle II MRI
Units Affected
46