Z-0641-05

Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of...

Name: Z-0641-05 Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of...
Creator: Heartsine Technologies Inc
Published: 2005-02-14
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2005-02-14 / Terminated / root cause: manufacturing process

FDA source

Heartsine Technologies Inc began a recall of Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected) on 2005-02-14. The reason FDA records is "The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0641-05
Status: Terminated
Initiated: 2005-02-14
Posted: 2005-03-23
Terminated: 2011-06-08
Recalling firm: HeartSine Technologies Ltd
Product: Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall was initiated by telephone 2/14/2005 with follow-up fax, email or postal mailing using one of several customized letters for distributors or customers. Customers will be sent an upgrade kit by overnite mail and forms to confirm upgrade.
Quantity in commerce: 672
Distribution: Nationwide to distributors and user facilities. Also to Argentina, Austria, Belgium, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Thailand, United Kingdom.
Product codes and lots: Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)