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Terminated

Zoll AED Plus Defibrillator (Automatic External Defibrillator)

FDA Recall Z-0548-03 · Posted 2003-02-06

Recalling FirmZoll Medical Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2002-12-17
Date Terminated2004-04-21
Product Quantity5,597 units

Reason for Recall

Defibrillator may fail to function due to false detection of safety fault condition

Firm Action

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

Distribution Pattern

Nationwide to : Hospitals, EMT, Police and Fire Rescue

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011388ZOLL PADZoll Medical Corp · 2002-03-25

Official Source

View FDA Recall →

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

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