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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 16, 2005
Date Posted November 03, 2005
Recall Status1 Terminated 3 on February 14, 2006
Recall Number Z-0063-06
Recall Event ID 33458
510(K)Number K842616  
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
Product Tru-Link DIN unshielded ECG cable, 5-lead
Code Information Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01
Recalling Firm/
Manufacturer		 Spacelabs Medical Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Al Van Houdt
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
FDA Determined
Cause 2		 Other
Action On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables.
Quantity in Commerce 632 cables
Distribution Cables were distributed to 9 US hospitals/medical centers and 30 international customers.
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 = DSI and Original Applicant = SPACELABS, INC.
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