Brampton, Ontario, Canada
O-Two Medical Technologies, Inc. recalls
2 recalls recorded since 2018, most recently on 12 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 12 February 2019
- Terminated
- 29 June 2023
- 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.
- Distribution
- The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0978-2019, Z-0977-2019, Z-0976-2019
- e700 Automatic Transport Ventilator, Model Number 01EVE700
- e600 Automatic Transport Ventilator, Model Number 01EVE600
- e500 Automatic Transport Ventilator, Model Number 01EVE500
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 3 June 2020
- Reason
- Higher levels of nitrous oxide delivered than specification
- Distribution
- AK, CA, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2885-2018
- O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.