The U.S. Food & Drug Administration has announced that O-Two Medical Technologies, Inc. has issued recalls on its e700, e600 and e500 Automatic Transport Ventilators due to potential risk of fire. According to the FDA announcement, “[t]hese 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.” The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Click here to see the full FDA notification and learn which serial numbers are affected.