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U.S. Department of Health and Human Services

Class 2 Device Recall AED 10 and MRL Jumpstart

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 Class 2 Device Recall AED 10 and MRL Jumpstartsee related information
Date Initiated by FirmApril 24, 2009
Date PostedJuly 06, 2009
Recall Status1 Terminated 3 on August 11, 2011
Recall NumberZ-1656-2009
Recall Event ID 51923
510(K)NumberK021168 
Product Classification automated external defibrillator - Product Code MKJ
ProductWelch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
Code Information software versions 2.03, 2.04, 2.05, and 2.06
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		Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to
FDA Determined
Cause 2		Labeling design
ActionThe firm has developed expanded labeling for users and will revise the user manuals for software versins 2.03, 2.04, 2.05, and 2.06. Customers receiving the updated manuals will be sent a cover letter directing them to discard the original user manual and replace it with the updated manual. The April 24, 2009, cover letter will highlight the clarification of directions for use regarding what to do when a low battery indicator is displayed.
Quantity in Commerce46740 units
DistributionWorldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MKJ
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