Date Initiated by Firm |
November 03, 2004 |
Date Posted |
November 20, 2004 |
Recall Status1 |
Terminated 3 on April 12, 2006 |
Recall Number |
Z-0200-05 |
Recall Event ID |
30378 |
Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
|
Product |
AccessAED Package (without audio record) Model Number: 9100-0150-0 |
Code Information |
Serial Numbers: 075180 through 084760 |
Recalling Firm/ Manufacturer |
Access CardioSystems 150 Baker Avenue Ext Ste 108 Concord MA 01742-2196
|
For Additional Information Contact |
Keith Proctor 978-405-1044
|
Manufacturer Reason for Recall |
Device may fail to deliver shock due to a faulty circuit board
|
FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
2995 units |
Distribution |
Nationwide
Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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