Class I Recall of O-Two Medical Technologies, Inc. Ventilators
The U.S. Food and Drug Administration (FDA) is informing health care providers of the following Class I recall:
- o_two e700, e600 and e500 Automatic Transport Ventilators
- Model Number: 01EVE700, 01EVE600 and 01EVE50
- Serial Numbers:
- e700: EV70001 to EV70658;
- e600: EV60001 to EV60126;
- e500: EV50001 to EV50148
- Distribution Dates: July 2013, to November 2018.
- Manufacturing Dates: July 2013, to January 2019.
- Devices Recalled in the U.S.: 469
These ventilators are being recalled because an improperly inserted screw in the ventilator screen may wear through the electrical insulation and create a short circuit that could lead the device to catch fire and injure the patient. Fires in oxygen rich environments in a hospital or other health care facility pose increased risk of serious injury or death to both patients and device users.
O-Two Medical Technologies’ e700, e600 and e500 Automatic Transport Ventilators are emergency and transport ventilators designed for use before arriving at the hospital, in the hospital, between hospitals, and in transport settings. These ventilators are intended for use with adult, child and infant patients who are in cardiac arrest or respiratory distress and need breathing support.
O-Two Medical Technologies provided the following recommendations:
- Customers are to stop using the device and immediately return any of the following units that have undergone Thin-Film-Transistor (TFT) screen replacement or have had service performance in the screen area. This includes units with serial numbers:
- EV50090-2016, EV60003-2014, EV60049-2016, EV70091-2014, EV70172-2015, EV70173-2015, EV70181-2015, EV70335-2016, EV70340-2016, EV70418-2017, EV70426-2017, EV70435-2017, EV70473-2017, EV70531-2017
- For all other customers, the firm instructed that they return their units for service inspection in accordance with the arrangements made by their local supplier for corrections to their ventilators.
- Complete and return the Medical Device Recall Return Response form enclosed with the firm’s recall notification, even if you do not have any affected o-two Automatic Transport Ventilators.
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