Z-2468-2011

Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous...

Name: Z-2468-2011 Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous...
Creator: Newport Medical Instruments Inc
Published: 2009-10-27
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2009-10-27 / Terminated / root cause: software

FDA source

Newport Medical Instruments Inc began a recall of Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or... on 2009-10-27. The reason FDA records is "Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2468-2011
Status: Terminated
Initiated: 2009-10-27
Posted: 2011-06-08
Terminated: 2011-06-08
Recalling firm: Newport Medical Instruments, Inc.
Product: Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
Root cause tag: software
FDA root cause: Mixed-up of materials/components
Action: Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.
Quantity in commerce: 18
Distribution: Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
Product codes and lots: Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877

Product code CBK

K053502Class IINewport E360 VentilatorNewport Medical Instruments, Inc. / cleared 2006-01-10

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)