FDA Medical Device Recalls (openFDA)
O-Two Medical Technologies, Inc.: e500 Automatic Transport Ventilator, Model Number 01EVE500
- Recall number
- Z-0976-2019
- Recalling firm
- O-Two Medical Technologies, Inc.
- Product
- e500 Automatic Transport Ventilator, Model Number 01EVE500
- Status
- Terminated
- Initiated
- 2019-02-12
- Posted
- 2019-04-04
- Terminated
- 2023-06-29
- 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.
- Lot, serial or model codes
- EV50001 to EV50148
- 510(k) numbers
- ["K141595"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 3002807836
- Firm city
- Brampton Canada
- Firm state
- Ontario
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28