Aug

2007

In, Class II Medtronic Emergency Response Systems

Company:Medtronic Emergency Response Systems, Inc
Date of Enforcement Report:8/8/2007
Class:ll

PRODUCT
Biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers), Recall # Z-1148-2007

REASON
Reduced Shock. The device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter dated June 11, 2007. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
59,996 units

DISTRIBUTION
Nationwide and Internationally

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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In, Class II Medtronic Emergency Response Systems

Amy Sellers

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