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Terminated

AccessAED Package (with audio record) Model Number: 9100-0150-1

FDA Recall Z-0202-05 · Posted 2004-11-20

Recalling FirmAccess CardioSystems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-11-03
Date Terminated2006-04-12
Product Quantity166 units

Reason for Recall

Device may fail to deliver shock due to a faulty circuit board

Firm Action

AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore

Official Source

View FDA Recall →

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

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