Recall Z-0199-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Access CardioSystems
AccessAED (without audio record) Model Number: 9100-0100-0
| Date | Nov 20, 2004 (initiated Nov 3, 2004) |
| Status | Terminated |
| Reason | Device may fail to deliver shock due to a faulty circuit board |
| Root cause | Other |
| Action | AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation. |
| Quantity | 1077 units |
| Distribution | Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020984 | ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS Access Cardiosystems, Inc., Aug 14, 2002 |