Z-2211-2009

Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some...

Name: Z-2211-2009 Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some...
Creator: Spacelabs Healthcare, Incorporated
Published: 2009-07-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-07-23 / Terminated / root cause: manufacturing process

FDA source

Spacelabs Healthcare, Incorporated began a recall of 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... on 2009-07-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2211-2009
Status: Terminated
Initiated: 2009-07-23
Posted: 2009-09-11
Terminated: 2011-07-21
Recalling firm: GE Healthcare
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Product code MHX

K090556Class IISpacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO / cleared 2009-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)