FDA Medical Device Recalls (openFDA)
Heartsine Technologies Inc: HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
- Recall number
- Z-1046-05
- Recalling firm
- Heartsine Technologies Inc
- Product
- HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
- Status
- Terminated
- Initiated
- 2005-10-05
- Posted
- 2005-07-28
- Terminated
- 2012-02-29
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Serial numbers within range of 0000101 and 00003986
- 510(k) numbers
- ["K023854"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3004018643
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28