06
Nov
2014

Class I Covidien Puritan Bennett 980 Ventilator

0

Company: Nellcor Puritan Bennett Inc. (dba Covidien LP).
Date of Enforcement Report 11/6/2014
Class I:

PRODUCT

Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Recall Number Z-0112-2015

REASON
A software issue may lead to ventilator inoperative situations.

RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett Inc. (dba Covidien LP, Boulder, CO) on 10/1/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
324 units

DISTRIBUTION
Nationwide and Internationally

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About the author

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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