Z-1656-2009

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

Name: Z-1656-2009 Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
Creator: Welch Allyn Protocol, Inc
Published: 2009-04-24
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2009-04-24 / Terminated / root cause: labeling and UDI

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10") on 2009-04-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1656-2009
Status: Terminated
Initiated: 2009-04-24
Posted: 2009-07-06
Terminated: 2011-08-11
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 46740 units
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.
Product codes and lots: software versions 2.03, 2.04, 2.05, and 2.06

Product code MKJ

K021168Class IIIJump Start, Model 970300Medical Research Laboratories, Inc. / cleared 2002-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)