Recall Z-0641-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Heartsine Technologies Inc
Heartsine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 1270 - 2324 (not all are affected).
| Date | Mar 23, 2005 (initiated Feb 14, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.