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U.S. Department of Health and Human Services

Class 1 Device Recall Welch Allyn AED

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  Class 1 Device Recall Welch Allyn AED see related information
Date Initiated by Firm December 15, 2008
Date Posted March 10, 2009
Recall Status1 Terminated 3 on February 15, 2012
Recall Number Z-1005-2009
Recall Event ID 50142
510(K)Number K021168  
Product Classification Automated External Defibrillator - Product Code MKJ
Product Welch Allyn AED 10 Automated External Defibrillator
Code Information Serial numbers: 002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, NA035807002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, and NA035807.
Recalling Firm/
Manufacturer		 Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton OR 97008
For Additional Information Contact
503-530-7935
Manufacturer Reason
for Recall		 Potential for device to shut down prematurely under certain circumstances.
FDA Determined
Cause 2		 Device Design
Action On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.
Quantity in Commerce 89 units
Distribution Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.
Total Product Life Cycle TPLC Device Report
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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