Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
This recall has been terminated (originally issued July 6, 2009).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- April 24, 2009
- Posted
- July 6, 2009
- Terminated
- August 11, 2011
- Recall Number
- Z-1656-2009
- Quantity
- 46740 units
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
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
Distribution
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.
Lot / Code Info
software versions 2.03, 2.04, 2.05, and 2.06
Root Cause
Labeling design
Action Taken
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.