HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
FDA device recall Z-1046-05 · posted 2005-07-28 · Terminated
Recall details
- Recalling firm
- Heartsine Technologies Inc
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, Pakist
- Date initiated
- 2005-10-05
- Date posted
- 2005-07-28
- Date terminated
- 2012-02-29
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAMARITAN AED, MODEL SAM-01 (K023854) | Heartsine Technologies, Inc. | 2003-02-14 |