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Terminated

Zoll M Series External Defibrillator

FDA Recall Z-1000-03 · Posted 2003-07-10

Recalling FirmZoll Medical Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2003-06-23
Date Terminated2020-12-29
Product Quantity8,142 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972241ZOLL REVIVERZoll Medical Corp · 1998-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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