15
Jan
2014

Cl II Puritan Bennett 840 ventilator systems

0

Company: Covidien.
Date of Enforcement Report:1/15/2014
Class lI:

PRODUCT

Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Recall Number Z-0611-2014

REASON
Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

RECALLING FIRM/MANUFACTURER
Covidien, Boulder, CO on 12/16/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16,756 US, 39,372 OUS

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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