Zoll AED Plus Defibrillator (Automatic External Defibrillator)
FDA device recall Z-0548-03 · posted 2003-02-06 · Terminated
Recall details
- Recalling firm
- Zoll Medical Corporation
- Reason for recall
- Defibrillator may fail to function due to false detection of safety fault condition
- Action taken
- Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 5,597 units
- Distribution
- Nationwide to : Hospitals, EMT, Police and Fire Rescue
- Date initiated
- 2002-12-17
- Date posted
- 2003-02-06
- Date terminated
- 2004-04-21
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL PAD (K011388) | Zoll Medical Corp | 2002-03-25 |