Zoll M Series External Defibrillator
FDA device recall Z-1000-03 · posted 2003-07-10 · Terminated
Recall details
- Recalling firm
- Zoll Medical Corporation
- Reason for recall
- Defibrillator may fail to charge or hold its charge above energies of 75 joules
- Action taken
- Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 8,142 units
- Distribution
- Nationwide Foreign: Emirates, Australia, Brussels, Brazil, Canada, China, Columbia, Chezche, Germany, Spain, Finland, France, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia,
- Date initiated
- 2003-06-23
- Date posted
- 2003-07-10
- Date terminated
- 2020-12-29
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL REVIVER (K972241) | Zoll Medical Corp | 1998-03-16 |