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