FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Incorporated: 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.
- Recall number
- Z-2211-2009
- Recalling firm
- Spacelabs Healthcare, Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2009-07-23
- Posted
- 2009-09-11
- Terminated
- 2011-07-21
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K090556"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28