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.
FDA Recall Z-2211-2009 · Posted 2009-09-11
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Recalling FirmSpacelabs Healthcare, Incorporated
Recall StatusTerminated
Product CodeMHX
Date Initiated2009-07-23
Date Terminated2011-07-21
Product Quantity1,395
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.
Firm 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).
Root Cause
Process control
Distribution Pattern
International Distribution -- Bangladesh, Turkey, Trinidad and Tobago, Romania, Guatemala, Algeria, Netherlands, Egypt, Chile, Venezuela, Spain, Colombia, India, the United Kingdom, Singapore, France and Ecuador.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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