AccessAED Package (without audio record) Model Number: 9100-0150-0
FDA Recall Z-0200-05 · Posted 2004-11-20
Recalling FirmAccess CardioSystems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-11-03
Date Terminated2006-04-12
Product Quantity2995 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.