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U.S. Department of Health and Human Services

Class 2 Device Recall ECG Cable

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  Class 2 Device Recall ECG Cable see related information
Date Initiated by Firm September 10, 2010
Date Posted October 12, 2011
Recall Status1 Terminated 3 on October 13, 2011
Recall Number Z-0041-2012
Recall Event ID 59418
510(K)Number K091513  
Product Classification Electrocardiograph - Product Code DPS
Product ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph

ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Code Information Lot Numbers: P09100310 P09100406 P09100428
Recalling Firm/
Manufacturer		 Edan Instruments, Inc.
7/F, Yuehai Office Bldg.
1128 Nanyou Road
Nanshan, Shenzhen Guangdong China
For Additional Information Contact Chao Lin
858-245-9298
Manufacturer Reason
for Recall		 The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have been no reports of injury as a result of this issue.
FDA Determined
Cause 2		 Vendor change control
Action Edan Instruments, Inc. sent an Urgent - Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that wrongly labeled cable may lead to incorrect ECG waveforms during ECG test, customers were reminded to review previous diagnoses made from this cable to mitigate any inappropriate recordings or treatment made. Customers were instructed to replace the affected ECG Cables once they receive the new ECG Cable, and collect all the affected ECG Cables and then destroy and dispose of them according to local regulations. Questions or concerns were directed to the following numbers: Oceania and Asia: +86 (755) 2689 8322 North America, South America: +86 (755) 2689 9914 Europe: +86 (755) 2669 4684
Quantity in Commerce 615 Ccables
Distribution Worldwide Distribution - USA (nationwide) and the countries of Dominica, Ecuador, Colombia, Honduras, Peru, Mexico, El Salvador, Guatemala, Venezuela, Uruguay, Chile, Panama, Nicaragua, Ecuador, Australia, Philippines, Malaysia, Indonesia, Chinese Taipei, & Spain
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 = DPS and Original Applicant = EDAN INSTRUMENTS, INC.
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