Recall Z-1000-03 ยท MKJ Automated External Defibrillators (Non-Wearable)
Zoll Medical Corporation
Zoll M Series External Defibrillator
| Date | Jul 10, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | Defibrillator may fail to charge or hold its charge above energies of 75 joules |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Mexico, Netherlands, Poland,Romania, Saudi Arabia, Syrai, Thailand, Turkey, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972241 | ZOLL REVIVER Zoll Medical Corp, Mar 16, 1998 |