Z-0977-2019Class I

e600 Automatic Transport Ventilator, Model Number 01EVE600

Name: Z-0977-2019 e600 Automatic Transport Ventilator, Model Number 01EVE600
Creator: O-Two Medical Technologies, Inc.
Published: 2019-02-12
License: https://open.fda.gov/license/

O-Two Medical Technologies, Inc. / initiated 2019-02-12 / Terminated / root cause: manufacturing process

FDA source

O-Two Medical Technologies, Inc. began a recall of e600 Automatic Transport Ventilator, Model Number 01EVE600 on 2019-02-12. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0977-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-12
Posted: 2019-04-04
Terminated: 2023-06-29
Recalling firm: O-Two Medical Technologies, Inc.
Product: e600 Automatic Transport Ventilator, Model Number 01EVE600
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 119
Distribution: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Product codes and lots: EV60001 to EV60126

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0976-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04
Z-0977-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04
Z-0978-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04

Product code BTL

K141595Class IIO-Two E700,o-Two E600,o-Two E500O-Two Medical Technologies, Inc. / cleared 2015-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)