Z-0977-2019 Class I Terminated
FDA device recall Z-0977-2019 was initiated by O-Two Medical Technologies, Inc. on February 12, 2019 and is designated Class I. 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 … The recall status is terminated (terminated June 29, 2023). Affected quantity: 119.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2019
- Initiation Date
- February 12, 2019
- Termination Date
- June 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119
Product Description
e600 Automatic Transport Ventilator, Model Number 01EVE600
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.
Code Information
EV60001 to EV60126