Recall Z-0977-2019— O-Two Medical Technologies, Inc.

Name: FDA recall Z-0977-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-12

Class I · Terminated

Class I FDA medical device recall by O-Two Medical Technologies, Inc., initiated 2019-02-12, terminated 2023-06-29. It names one FDA 510(k) clearance: K141595. Product: e600 Automatic Transport Ventilator, Model Number 01EVE600. 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..

Recalling firm: O-Two Medical Technologies, Inc.
Classification: Class I
Status: Terminated
Initiated: 2019-02-12
Terminated: 2023-06-29
Firm location: Brampton, Ontario, Canada

510(k) clearances named in this recall

1 on FDA's record

K141595 — O-TWO E700,O-TWO E600,O-TWO E500O-Two Medical Technologies, Inc.·cleared 2015-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

e600 Automatic Transport Ventilator, Model Number 01EVE600

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.