e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Recall Z-0977-2019 · Posted 2019-04-04
Recalling FirmO-Two Medical Technologies, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2019-02-12
Date Terminated2023-06-29
Product Quantity119
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.