Z-1046-05

HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003

Name: Z-1046-05 HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003
Creator: Heartsine Technologies Inc
Published: 2005-10-05
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2005-10-05 / Terminated / root cause: design

FDA source

Heartsine Technologies Inc began a recall of HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003 on 2005-10-05. The reason FDA records is "Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1046-05
Status: Terminated
Initiated: 2005-10-05
Posted: 2005-07-28
Terminated: 2012-02-29
Recalling firm: HeartSine Technologies Ltd
Product: HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.
Root cause tag: design
FDA root cause: Device Design
Action: AED software revision 1.0.20 and higher incorporate software enhancements to make the AED more forgiving for extreme variations in user technique. Firm will provide distributors with field correction notice dated 10/5/05. Customers to be notified by mid-October 2005.
Quantity in commerce: 1929 units
Distribution: Nationwide, Puerto Rico, Argentina, Australia, Austria, Belgium, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Netherlands, Pakistan, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, UK
Product codes and lots: Serial numbers within range of 0000101 and 00003986

Product code MKJ

K023854Class IIISamaritan AED, Model Sam-01Heartsine Technologies, Inc. / cleared 2003-02-14

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)