Devices

Device Recall Spacelabs Medical Integrated ECG Cable

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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 Description
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.
Manufacturer
Spacelabs Healthcare, Incorporated
1 Event
- Recall of Device Recall Spacelabs Medical Integrated ECG Cable

Manufacturer

Spacelabs Healthcare, Incorporated

Manufacturer Address
Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
Source
USFDA

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