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Terminated

Access AED and Access ALS Automated External Defibrillators Model No. : 9100-0100

FDA Recall Z-0356-04 · Posted 2004-07-20

Recalling FirmAccess CardioSystems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2003-12-19
Date Terminated2004-07-13
Product Quantity143 units

Reason for Recall

Difibrillator may fail to operate due to a faulty component on the circuit board

Firm Action

Access CardioSystems notified Distributors by telephone and email on 12/18/03 and 12/19/03. Recall letters were dated 12/19/03 and issued by US Mail. Distributors are requested to locate and return AED's .

Root Cause

Other

Distribution Pattern

AL, CA, LA, FL, OR, NC,TN,. Foreign: Grenada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020984ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORSAccess Cardiosystems, Inc. · 2002-08-14

Official Source

View FDA Recall →

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

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