Data Foundry

Medical device recalls 2019

e700 Automatic Transport Ventilator — Class I medical device recall Z-0978-2019

Terminated recall by O-Two Medical Technologies, Inc., reported 2019-04-10, distributed in AZ, CA, CO, FL, OH, PA, TX, VA. There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly in

Recall numberZ-0978-2019
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmO-Two Medical Technologies, Inc., Brampton, Ontario, Canada
Recall initiated2019-02-12
Classified2019-04-04
Reported by FDA2019-04-10
Terminated2023-06-29
DistributedAZ, CA, CO, FL, OH, PA, TX, VA
Quantity632
Reason classesdevice malfunction
Model numbers01EVE700

Product

e700 Automatic Transport Ventilator, Model Number 01EVE700

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0978-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.