Critical FDA (Devices)·Z-0977-2019·Announced 2019-04-10

O-Two Medical e600 Ventilator Recalled for Fire Risk

O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.

Plain-English summary

O-Two Medical Technologies, Inc. is recalling 119 units of the e600 Automatic Transport Ventilator, Model Number 01EVE600. The recall involves serial numbers EV60001 through EV60126. The affected products were distributed to Arizona, California, Colorado, Florida, Ohio, Pennsylvania, Texas, and Virginia.

The recall is due to a potential fire hazard. In some units, one of the screen retaining screws was incorrectly inserted, causing it to sit higher than normal. This allowed the screw to contact the underside of the main board, wearing away the insulation layer and creating a short circuit that could lead to a fire.

This is an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Consumers and healthcare facilities should stop using the affected ventilators immediately and contact O-Two Medical Technologies for instructions on repair or replacement.

The recalled product

Product: e600 Automatic Transport Ventilator, Model Number 01EVE600
Manufacturer: O-Two Medical Technologies, Inc.
Category: Medical Device — Ventilator
Hazard: fire
Affected units: 119

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

EV60001 to EV60126

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 3 recalled by O-Two Medical Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · O-Two Medical Technologies, Inc.

See all →

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Same hazard · fire