ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph

FDA device recall Z-0041-2012 · posted 2011-10-12 · Terminated

Recall details

Recalling firm

Edan Instruments, Inc.

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 taken

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

Root cause

Vendor change control

Status

Terminated

Product code

DPS

Quantity affected

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, Austr

Date initiated

2010-09-10

Date posted

2011-10-12

Date terminated

2011-10-13

Location

Shenzhen, Guangdong, China

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