Z-0918-04

Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL...

Name: Z-0918-04 Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL...
Creator: MRL, Inc., A Welch Allyn Company
Published: 2004-04-26
License: https://open.fda.gov/license/

MRL, Inc., A Welch Allyn Company / initiated 2004-04-26 / Terminated

FDA source

MRL, Inc., A Welch Allyn Company began a recall of Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo... on 2004-04-26. The reason FDA records is "A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0918-04
Status: Terminated
Initiated: 2004-04-26
Posted: 2004-07-20
Terminated: 2004-11-15
Recalling firm: MRL, Inc., A Welch Allyn Company
Product: Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
Product code: MKJ--
Reason for recall: A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
FDA root cause: Other
Action: Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement unit. A follow-up letter will accompany the replacement unit with instructions on how to verify the affected units, packing instructions for the return of the affected units to Welch Allyn MRL, and a correction response form to be completed and enclosed with the returned unit.
Quantity in commerce: 460 units
Distribution: Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa.
Product codes and lots: part numbers 970300 and 970302; serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926

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)