Date Initiated by Firm | November 03, 2004 |
Date Posted | November 20, 2004 |
Recall Status1 |
Terminated 3 on April 12, 2006 |
Recall Number | Z-0205-05 |
Recall Event ID |
30378 |
Product Classification |
Automated External Defibrillators (Non-Wearable) - Product Code MKJ
|
Product | AccessAED PAD (without ECG trace) -Public Access Defibrillator
Model Number: 9100-0010-0 |
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 | 568 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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