Newport Medical Instruments Inc 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 gen Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 gen
Brand
Newport Medical Instruments Inc
Lot Codes / Batch Numbers
Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877
Products Sold
Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877
Newport Medical Instruments Inc is recalling Newport e360 Ventilator, Model Number: e360 The e360 Ventilator System is intended to provide conti due to Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026