FDA Device recall Z-0977-2019
e600 Automatic Transport Ventilator, Model Number 01EVE600
- FDA Device
- Class I
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class I recall of e600 Automatic Transport Ventilator, Model Number 01EVE600 by O Two Medical Technologies, citing 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 tha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0977-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-02-12 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | O Two Medical Technologies |
| Distribution | AZ, CA, CO, FL, OH, PA, TX, VA |
Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Reason
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.
Identifiers
| code_info | EV60001 to EV60126 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2019%22
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