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U.S. Department of Health and Human Services

Class 2 Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors

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  Class 2 Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors see related information
Date Initiated by Firm March 24, 2010
Date Posted May 07, 2010
Recall Status1 Terminated 3 on January 23, 2014
Recall Number Z-1547-2010
Recall Event ID 55115
510(K)Number K042007  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA.

Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
Code Information Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
Recalling Firm/
Manufacturer		 ZOLL Medical Corporation, World Wide Headquarters
269 Mill Rd
Chelmsford MA 01824
For Additional Information Contact Paul Dias
978-421-9413
Manufacturer Reason
for Recall		 Device issued Shock Advised message but failed to auto-charge the defibrillator.
FDA Determined
Cause 2		 Software design
Action Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.
Quantity in Commerce 1383 units
Distribution Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
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 = MKJ and Original Applicant = ZOLL MEDICAL CORP.
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