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.
This recall has been terminated (originally issued September 11, 2009).
- Recall Initiated
- July 23, 2009
- Posted
- September 11, 2009
- Terminated
- July 21, 2011
- Recall Number
- Z-2211-2009
- Quantity
- 1,395
- Firm Location
- Issaquah, WA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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).