e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA device recall Z-0978-2019 · posted 2019-04-04 · Terminated
Recall details
- Recalling firm
- O-Two Medical Technologies, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 632
- Distribution
- The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
- Date initiated
- 2019-02-12
- Date posted
- 2019-04-04
- Date terminated
- 2023-06-29
- Location
- Brampton Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-TWO E700,O-TWO E600,O-TWO E500 (K141595) | O-Two Medical Technologies, Inc. | 2015-03-16 |