Date Initiated by Firm |
August 02, 2004 |
Date Posted |
September 17, 2004 |
Recall Status1 |
Terminated 3 on February 13, 2017 |
Recall Number |
Z-1472-04 |
Recall Event ID |
29959 |
510(K)Number |
K010257
|
Product Classification |
Hepatitis Viral B Dna Detection - Product Code MKT
|
Product |
Zoll M Series Automated Defibrillator (AED) |
Code Information |
Software Versions below 34.00 |
Recalling Firm/ Manufacturer |
Zoll Medical Corporation 269 Mill Rd Chelmsford MA 01824-4105
|
For Additional Information Contact |
Paul Dias 978-421-9413
|
Manufacturer Reason for Recall |
Visual Sreen display and audible prompt may not advise to 'Press Shock'
|
FDA Determined Cause 2 |
Other |
Action |
Zoll Medical notified consignees by letter on 8/2/04 via Certified Mail. Users are advised of the problem and the softtware upgrade. |
Quantity in Commerce |
5649 units |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = MKT and Original Applicant = ZOLL MEDICAL CORP.
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