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Terminated

e500 Automatic Transport Ventilator, Model Number 01EVE500

FDA Recall Z-0976-2019 · Posted 2019-04-04

Recalling FirmO-Two Medical Technologies, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2019-02-12
Date Terminated2023-06-29
Product Quantity136

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.

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