Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure
Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical medical device where a failure of the audible alarm could lead to delayed response to patient distress, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling 5,765 single board computer components (part number SBC2105A) used in the Newport Medical Instruments e360 Ventilator. The recall is due to reports that the audible alarm may not sound when the ventilator is in an alarm state. The visual and remote alarms continue to operate normally.
The affected components are identified by serial numbers N11360719000 through N14360426029. These components are intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact the manufacturer for instructions on how to address the issue.
The recalled product
- Product
- Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure…
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Hazard
- Affected units
- 5,765
Distribution
Related recalls
Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)
See all →- SevereCovidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
FDA (Devices) · 2014-11-05
- HighVital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch
FDA (Devices) · 2014-08-20
- ModerateVital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch
FDA (Devices) · 2014-08-20
- HighPuritan Bennett 840 Ventilator Recall for Display Loss
FDA (Devices) · 2014-07-02
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- SevereVentilator Audible and Visual Alarms May Not Activate During Alarm States
FDA (Devices) · 2022-05-04
- SevereCovidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
FDA (Devices) · 2014-11-05
- SevereNewport HT70 Ventilators Recalled for Control Board Failure Risk
FDA (Devices) · 2012-09-12
- SevereCovidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall
FDA (Devices) · 2025-06-18
- HighNellcor Puritan Bennett PB840 Ventilator Display Component Recalled
FDA (Devices) · 2014-06-25