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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn AED 10 Defibrillator

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  Class 2 Device Recall Welch Allyn AED 10 Defibrillator see related information
Date Initiated by Firm April 26, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 15, 2004
Recall Number Z-0918-04
Recall Event ID 28880
510(K)Number K021168  
Product Classification unknown device name - Product Code MKJ--
Product Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
Code Information part numbers 970300 and 970302; 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
Recalling Firm/
Manufacturer		 MRL, Inc., A Welch Allyn Company
1000 Asbury Dr Ste 17
Buffalo Grove IL 60089-4551
For Additional Information Contact Mr. Marvin T. Iglehart
847-520-0300
Manufacturer Reason
for Recall		 A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
FDA Determined
Cause 2		 Other
Action Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.
Quantity in Commerce 460 units
Distribution Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ-- and Original Applicant = MEDICAL RESEARCH LABORATORIES, INC.
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