FDAClass IApril 10, 2019

e600 Automatic Transport Ventilator recall

e600 Automatic Transport Ventilator, Model Number 01EVE600

Why was e600 Automatic Transport Ventilator 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

EV60001 to EV60126

Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Recalling firm
O-Two Medical Technologies, Inc.
Quantity
119
Distribution
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Recall date
April 10, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls