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U.S. Department of Health and Human Services

Class 2 Device Recall AED 10

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  Class 2 Device Recall AED 10 see related information
Date Initiated by Firm February 26, 2009
Date Posted June 23, 2009
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-1389-2009
Recall Event ID 51496
510(K)Number K021168  
Product Classification automated external defibrillator - Product Code MKJ
Product Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
Code Information Blown fuse serial numbers: 008577 - 013143 inclusive. Voice prompt serial numbers: 002002 - 008286 inclusive, and 008289 008291 008293 008296 008297 008298 008299 008300 008301 008302 008303 008304 008305 008306 008307 008308 008309 008310 008311 008312 008313 008314 008315 008316 008322 008323 008324 008325 008326 008327 008328 008329 008330 008331 008332 008333 008334 008335 008336 008337 008339 008340 008362 008363 008364 008365 008366 008367 008368 008369 008370 008372 008373 008374 008375 008376 008377 008378 008379 008402 008403 008404 008405 008406 008407 008411 008413 008414 008415 008416 008417 008418 008419 008420 008421 008422 008423 008424 008425 008426 008427 008428 008429 008430 008431 008432 008435 008446 008524 008525 008583 008656 008671 008712 008714 008724 008742 008743 008744 008792 008856 008864 008911 008913 008943 008988 009007 009009 009010 009015 009016 009017 009066 009067 009070 009071 009072 009073 009074 009075 009076 009079 009081 009083 009085 009086 009087 009122 009123 009124 009126 009127 009128 009129 009130 009139 009715 009813 010108 010168 012603 013659 013665 013727 016604 019508 020910 020911 020912 022356  and 027224.
Recalling Firm/
Manufacturer		 Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton OR 97008
For Additional Information Contact Rich Wynkoop
888-345-5356
Manufacturer Reason
for Recall		 Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.
FDA Determined
Cause 2		 Component design/selection
Action Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.
Quantity in Commerce Issue #1: 4568 units; Issue#2: 5186 units
Distribution Worldwide distribution.
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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