CLASS I Device recall · Reported 10 Apr 2019 · FDA Enforcement Report
e600 Automatic Transport Ventilator recalled
O-Two Medical Technologies is recalling e600 Automatic Transport Ventilator, distributed in 8 states. The recall was initiated on 12 Feb 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0977-2019
- FDA event ID
- 82178
- Recalling firm
- O-Two Medical Technologies, Brampton, Ontario
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 12 Feb 2019
- FDA classified
- 4 Apr 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 12 Feb 2019 | Recall initiated by company | |
| 4 Apr 2019 | Classified by FDA | +51 days |
| 10 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
e600 Automatic Transport Ventilator, Model Number 01EVE600
Where it was distributed
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
ArizonaCaliforniaColoradoFloridaOhioPennsylvaniaTexasVirginia
Questions about this recall
Is e600 Automatic Transport Ventilator recalled?
Yes. O-Two Medical Technologies recalled e600 Automatic Transport Ventilator on 12 Feb 2019. The recall is Class I and its status is Terminated. Recall number Z-0977-2019.
Why was it recalled?
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.
Which lots are affected?
EV60001 to EV60126
Where was it sold?
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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