Medical Device Recall: Z-0041-2012

FDA Recalls dataset · Firm: Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-09-10 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2012.

Recall Res Number
Z-0041-2012
FEI Number
3003971136
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-09-10
Date Posted
2011-10-12
Date Terminated
2011-10-13
Product Code
DPS
Event Number
59418
Product Quantity
615 Ccables
Product Description 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.
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.
Action Details 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
Distribution Pattern 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
Code Information / Serial Numbers Lot Numbers: P09100310 P09100406 P09100428

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