21

May

2014

Cl II Newport Medical Instruments e360 Ventilator

0

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Date of Enforcement Report:5/21/2014
Class lI:

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 or respiratory insufficiency.
Recall Number Z-1577-2014

REASON
Newport Medical Instruments, Inc. is conducting a voluntary field corrective action on specific Newport” e360 ventilators with a particular single board computer (SBC), in response to customer reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.

RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett Inc. (dba Covidien LP) Boulder, CO on 4/182014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
5,765

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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