e500 Automatic Transport Ventilator — Class I medical device recall Z-0976-2019
Terminated recall by O-Two Medical Technologies, Inc., reported 2019-04-10, distributed in AZ, CA, CO, FL, OH, PA, TX, VA. There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly in
| Recall number | Z-0976-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | O-Two Medical Technologies, Inc., Brampton, Ontario, Canada |
| Recall initiated | 2019-02-12 |
| Classified | 2019-04-04 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2023-06-29 |
| Distributed | AZ, CA, CO, FL, OH, PA, TX, VA |
| Quantity | 136 |
| Reason classes | device malfunction |
| Model numbers | 01EVE500 |
Product
e500 Automatic Transport Ventilator, Model Number 01EVE500
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0976-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.