Inc Class II Medtronic Emergency Response Systems

Company:Medtronic Emergency Response Systems, Inc.,
Date of Enforcement Report:12/27/2006
Class:ll

PRODUCT
LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007

REASON
LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

CODE
Devices with software version -028, -030, -032, and -038.

RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond WA, by letter dated December 2006 another in January 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10,307 devices

DISTRIBUTION
Nationwide and Internationally

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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