Recall Z-1046-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Heartsine Technologies Inc
HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003.
| Date | Jul 28, 2005 (initiated Oct 5, 2005) |
| Status | Terminated |
| 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, Thaila |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023854 | SAMARITAN AED, MODEL SAM-01 Heartsine Technologies, Inc., Feb 14, 2003 |