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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare CardioExpress SL6 ECG cable

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  Class 2 Device Recall Spacelabs Healthcare CardioExpress SL6 ECG cable see related information
Date Initiated by Firm September 10, 2010
Date Posted January 13, 2012
Recall Status1 Terminated 3 on January 13, 2012
Recall Number Z-0743-2012
Recall Event ID 60803
510(K)Number K090367  
Product Classification Electrocardiograph - Product Code DPS
Product 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.
Code Information Serial numbers:  98400-SL6-AHA1030508, 98400-SL6-AHA1030509, 98400-SL6-AHA1030510, 98400-SL6-AHA1030511, 98400-SL6-AHA1030512, 98400-SL6-AHA1030513, 98400-SL6-AHA1030514, 98400-SL6-AHA1030515, 98400-SL6-AHA1030516, 98400-SL6-AHA1030517, 98400-SL6-AHA1030518, 98400-SL6-AHA1030519, 98400-SL6-AHA1030520, 98400-SL6-AHA1030521, 98400-SL6-AHA1030522.
Recalling Firm/
Manufacturer		 Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford United Kingdom
For Additional Information Contact Technical Support
425-657-7200
Manufacturer 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).
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 15 units
Distribution Nationwide distribution.
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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