AED Recalls

Alert Details for #2004080157 (Released 8/13/2004 10:27 EDT)
Description: Zoll M series defibrillator - AED Model with System Software Version below 34.00
Manufacturer: Zoll Medical Corp.
Reason: A software defect has been found that causes affected M Series AEDs, under certain conditions, to skip the 'Press Shock' prompt after correctly advising the user of a shockable ECG rhythm, charging and enabling/illuminating the shock button. When this condition occurs, the unit indicates it is ready to discharge correctly but skips the visual screen display and audible prompt advising to 'Press Shock'.
Analyst Comments: Please click on the hyperlinked 'Source' in the Links field to open and read the attached pdf file. Confirm receipt of manufacturer's notice dated July 27, 2004. Follow manufacturer's instructions for correction. The attached file includes complete details of this safety alert. Users with questions should call Zoll at: 800-348-9011.

Alert Type: Recall  Source Alert Type: --
Domain: Biomedical Devices Source Type: Manufacturer
Distribution:   Source Date: 8/12/2004

Links:
AED2004080157.pdf

Product Information
Product Description Model/Product Number Stock Identifiers Volume Recall ID
Zoll M series defibrillator AED Model with System Software Version below 34.00 The following software versions have this defect; 13.35. 13.60, 15.70, 16.76, 16.82, 16.87, 16.92, 17.26, 17.55, 17.42, 18.36, 18.41, 22.55, 30.00, 30.50, 31.00, 32.00, 32.50 and 33.00. Not specified N/A