e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Device Recall #Z-0978-2019 — Class I — February 12, 2019
Recall Summary
| Recall Number | Z-0978-2019 |
| Classification | Class I — Serious risk |
| Date Initiated | February 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | O-Two Medical Technologies, Inc. |
| Location | Brampton, Ontario |
| Product Type | Devices |
| Quantity | 632 |
Product Description
e700 Automatic Transport Ventilator, Model Number 01EVE700
Reason for Recall
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Distribution Pattern
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Lot / Code Information
EV70001 to EV70658
Other Recalls from O-Two Medical Technologies, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0977-2019 | Class I | e600 Automatic Transport Ventilator, Model Num... | Feb 12, 2019 |
| Z-0976-2019 | Class I | e500 Automatic Transport Ventilator, Model Num... | Feb 12, 2019 |
| Z-2885-2018 | Class II | O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mix... | May 14, 2018 |
| Z-2731-2017 | Class II | Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 0... | Sep 30, 2015 |
| Z-2705-2017 | Class II | O-Two Adult Ventilation Timer, MODEL #(s): 01B... | Jun 23, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.