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Terminated

Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")

FDA Recall Z-1656-2009 · Posted 2009-07-06

Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-04-24
Date Terminated2011-08-11
Product Quantity46740 units

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

Firm Action

The 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021168JUMP START, MODEL 970300Medical Research Laboratories, Inc. · 2002-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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