Recall Z-0356-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
Access CardioSystems
Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
| Date | Jul 20, 2004 (initiated Dec 19, 2003) |
| Status | Terminated |
| Reason | Difibrillator may fail to operate due to a faulty component on the circuit board |
| Root cause | Other |
| Action | Access CardioSystems notified Distributors by telephone and email on 12/18/03 and 12/19/03. Recall letters were dated 12/19/03 and issued by US Mail. Distributors are requested to locate and return AED's . |
| Quantity | 143 units |
| Distribution | AL, CA, LA, FL, OR, NC,TN,. Foreign: Grenada |
| 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 |