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Terminated

Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

FDA Recall Z-0743-2012 · Posted 2012-01-13

Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeDPS
Date Initiated2010-09-10
Date Terminated2012-01-13
Product Quantity15 units

Reason for Recall

CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. 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).

Firm Action

Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to one affected customer in Massachusetts. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to review previous diagnoses made from this electrocardiograph to mitigate any inappropriate recordings or treatment made, and dispose of the mislabeled ECG cable to prevent its use. Spacelabs replaced the affected ECG cable with the new ECG cable. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root Cause

Employee error

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090367SE-601 SERIES ELECTROCARDIOGRAPHEdan Instruments, Inc. · 2009-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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