Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100
FDA device recall Z-0356-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Access CardioSystems
- Reason for recall
- Difibrillator may fail to operate due to a faulty component on the circuit board
- Action taken
- 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 .
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 143 units
- Distribution
- AL, CA, LA, FL, OR, NC,TN,. Foreign: Grenada
- Date initiated
- 2003-12-19
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-13
- Location
- Concord, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS (K020984) | Access Cardiosystems, Inc. | 2002-08-14 |