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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Medical Integrated ECG Cable

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  Class 2 Device Recall Spacelabs Medical Integrated ECG Cable see related information
Date Initiated by Firm July 23, 2009
Date Posted September 11, 2009
Recall Status1 Terminated 3 on July 21, 2011
Recall Number Z-2211-2009
Recall Event ID 53124
510(K)Number K090556  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25.

The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.
Code Information Part Numbers: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25; Date Codes: OSC 12/08, LHI 02/09, LHI 03/09, LHI 04/09, and LHI 5/09.   ALL OTHER DATE CODES FUNCTION NORMALLY AND ARE NOT SUBJECT TO THIS RECALL.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.
FDA Determined
Cause 2		 Process control
Action Spacelabs Healthcare issued an "Urgent: Medical Device Recall" dated July 20, 2009. Consignees are being sent replacement ECG cables for each item ordered and are requested to replace the affected cables. Also, they are instructed to destroy and dispose of the recalled cables according to their own protocol or local regulations. For further information, contact Spacelabs Healthcare Technical Support at 1-800-522-7025, option 2 (US) or +86-512-87171888, extension 304 (outside US).
Quantity in Commerce 1,395
Distribution International Distribution -- Bangladesh, Turkey, Trinidad and Tobago, Romania, Guatemala, Algeria, Netherlands, Egypt, Chile, Venezuela, Spain, Colombia, India, the United Kingdom, Singapore, France and Ecuador.
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 = MHX and Original Applicant = SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO
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