FDA Device

Zoll M Series External Defibrillator

Hazard

Defibrillator may fail to charge or hold its charge above energies of 75 joules

What You Should Do

Remedy

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.

Products

Zoll M Series External Defibrillator
Brand
Zoll Medical Corporation
UPC
Serial Numbers: T02I37097-T03C45238

Units Affected

8,142 units