Recall Z-0976-2019 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
O-Two Medical Technologies, Inc.
e500 Automatic Transport Ventilator, Model Number 01EVE500
| Date | Apr 4, 2019 (initiated Feb 12, 2019) |
| Status | Terminated |
| 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. |
| Root 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 | 136 |
| Distribution | The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 O-Two Medical Technologies, Inc., Mar 16, 2015 |