Drug recall
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA recall event 82178 · Class I · O-Two Medical Technologies, Inc.
Key facts
| Event ID | 82178 |
|---|---|
| Recall numbers | Z-0976-2019, Z-0977-2019, Z-0978-2019 |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Product type | Devices |
| Products | e500 Automatic Transport Ventilator, Model Number 01EVE500, e600 Automatic Transport Ventilator, Model Number 01EVE600, e700 Automatic Transport Ventilator, Model Number 01EVE700 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 12, 2019 |
| Report date | Apr 10, 2019 |
| Termination date | Jun 29, 2023 |
| City | Brampton |
| Country | Canada |
| FEI number | 3002807836 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: