AED Recalls

AED Recalls

Alert Details for #2004050177 (Released 5/20/2004 10:18 EDT)
Description: Welch Allyn AED 10 Defibrillator
Manufacturer: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL
Reason: A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED 10 defibrillator.

Alert Type: Recall  Source Alert Type: FDA Recall Class II
Domain: Biomedical Devices Source Type: FDA Enforcement Report
Distribution: Nationwide and Internationally Source Date: 5/19/2004

Links:
http://www.fda.gov/opacom/Enforce.html

Product Information
Product Description Model/Product Number Stock Identifiers Volume Recall ID
Welch Allyn AED 10 Defibrillator (a battery powered automated external defibrillator) Model AED 10, part number 970300 (defibrillator) Serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926. 460 Units total. Z-0918-04
Welch Allyn AED 10 Defibrillator (a battery powered automated external defibrillator) Model AED 10, part number 970302 (defibrillator with soft shell carrying case). Serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926. 460 Units total. Z-0918-04