Recall Z-0977-2019
O-Two Medical Technologies, Inc. · initiated February 12, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Codes / lots: EV60001 to EV60126
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.
FDA-determined cause: Process control
Action taken
Urgent Medical Device Correction notification letters dated 2/7/19 were sent to customers. An additional letter was sent to customers on 3/4/19.
Details
- Recall number
- Z-0977-2019
- Initiated
- February 12, 2019
- Posted by FDA
- April 4, 2019
- Terminated
- June 29, 2023
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 119
- Distribution
- The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
- Recalling firm
- O-Two Medical Technologies, Inc., Brampton Canada, Ontario
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0976-2019 Class I | e500 Automatic Transport Ventilator, Model Number 01EVE500There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly… | 02/12/2019Terminated |
| Z-0978-2019 Class I | e700 Automatic Transport Ventilator, Model Number 01EVE700There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly… | 02/12/2019Terminated |