U.S. Food and Drug Administration recently issued the following announcement.
Date Initiated by Firm: February 12, 2019
Create Date: April 04, 2019
Recall Status: Open, Classified
Recall Number: Z-0978-2019
Recall Event ID: 82178
510(K)Number: K141595
Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL
Product: e700 Automatic Transport Ventilator, Model Number 01EVE700
Code Information: EV70001 to EV70658
Recalling Firm/Manufacturer: O-Two Medical Technologies, Inc.
45A Armthorpe Road
Brampton Canada L6T 5M4
Ontario
For Additional Information Contact: Brenda Chard
905-792-6896
Manufacturer Reason
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.
FDA Determined Cause: Process control
Action: Urgent Medical Device Correction notification letters dated 2/7/19 were sent to customers.
An additional letter was sent to customers on 3/4/19.
Quantity in Commerce: 632
Distribution: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Total Product Life Cycle: TPLC Device Report
Original source can be found here.
