Edan Instruments, Inc.: 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.

Recall number

Z-0041-2012

Recalling firm

Edan Instruments, Inc.

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.

Status

Terminated

Initiated

2010-09-10

Posted

2011-10-12

Terminated

2011-10-13

Reason

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.

Root cause

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

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

Lot, serial or model codes

Lot Numbers: P09100310 P09100406 P09100428

510(k) numbers

["K091513"]

PMA numbers

not on file

Product code

DPS

Firm FEI

3003971136

Firm city

Shenzhen

Firm state

Guangdong

Firm country

China

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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