Severe FDA (Devices)·Z-0978-2019·Announced 2019-04-10

O-Two Medical e700 Ventilator Recalled for Fire Risk

O-Two Medical Technologies is recalling 632 e700 Automatic Transport Ventilators because a manufacturing defect could cause the unit to catch fire.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a fire hazard, which poses a risk of significant injury or property damage, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

O-Two Medical Technologies, Inc. is recalling 632 units of the e700 Automatic Transport Ventilator, Model Number 01EVE700. The recall affects units with serial numbers ranging from EV70001 to EV70658. These devices were distributed to healthcare facilities in 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 improper placement allowed the screw to contact the underside of the main board. As the screw rubbed against the board, it wore away the insulation layer, creating a short circuit that could lead to the unit catching fire.

Healthcare facilities that received these devices should stop using the affected units immediately. O-Two Medical Technologies is the firm responsible for the recall and is managing the corrective actions for the 632 affected units.

The recalled product

Product: e700 Automatic Transport Ventilator, Model Number 01EVE700
Manufacturer: O-Two Medical Technologies, Inc.
Category: Medical Device — Ventilator
Hazard: fire
Affected units: 632

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)

EV70001 to EV70658

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 →

Severe
O-Two Medical e500 Ventilator Recalled for Fire Hazard
FDA (Devices) · 2019-04-10
Critical
O-Two Medical e600 Ventilator Recalled for Fire Risk
FDA (Devices) · 2019-04-10
High
O-Two Equinox Relieve Gas System Recalled for High Nitrous Oxide Levels
FDA (Devices) · 2018-08-29
High
O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction
FDA (Devices) · 2017-07-19
High
O-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns
FDA (Devices) · 2017-07-19

Same hazard · fire