Agency classClass IOur severity:Severe FDA (Devices)·Z-0976-2019·Announced 2019-04-10

O-Two Medical e500 Ventilator Recalled for Fire Hazard

O-Two Medical is recalling 136 e500 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 potential for fire, which constitutes a significant injury risk under the rubric for significant injury/property-damage reports or high-risk hazards.

Plain-English summary

O-Two Medical Technologies, Inc. is recalling 136 units of the e500 Automatic Transport Ventilator, Model Number 01EVE500. The affected units have serial numbers ranging from EV50001 to EV50148. These products were distributed to hospitals and healthcare facilities in Arizona, California, Colorado, Florida, Ohio, Pennsylvania, Texas, and Virginia.

The recall is due to a potential fire hazard. In some units, a screen retaining screw was incorrectly inserted, causing it to sit higher than normal. This improper placement 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.

Healthcare facilities should immediately stop using the affected e500 Automatic Transport Ventilators. O-Two Medical Technologies, Inc. is the recalling firm and will provide instructions for the return or repair of the devices.

The recalled product

Product: e500 Automatic Transport Ventilator, Model Number 01EVE500
Manufacturer: O-Two Medical Technologies, Inc.
Category: Medical Device — Ventilator
Hazard: fire
Affected units: 136

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)

EV50001 to EV50148

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 e700 Ventilator Recalled for Fire Risk
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