The following information relates to FDA's decision to issue a Class I recall for this product. Additional information about Class I Medical Device Recalls can be found on the CDRH Recall Page.
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Date Recall
Initiated |
July 20, 2001 |
|---|---|
|
Product:
|
Solar 9500 Physiological ECG Monitor |
|
Use:
|
To monitor patient vital signs including blood pressure, pulse, temperature, cardiac output, respiration, and anesthetic gas concentrations during surgery. This product is intended for use under the direct supervision of a licensed health care practitioner. |
|
Recalling Firm:
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General Electric Medical Systems, Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223 |
|
Reason for Recall:
|
Incorrect computer chips were installed in the monitors. These incorrect chips could result in the loss of monitoring information or failure of the monitor to operate. |
|
Public Contact:
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Mr. Mark Stauffer Quality Assurance Manager Phone: 414-362-2703 |
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FDA District:
|
Minneapolis District Office |
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FDA Comment:
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Until correct computer chips are installed in these monitors FDA considers there to be a life threatening risk from use of this product. |
For additional information on this product recall, see the FDA Enforcement Report locate at: http://www.fda.gov/bbs/topics/enforce/2002/ENF00730.html. Scroll down to "Recalls and Field Corrections: Device - Class 1".
Updated July 10, 2002
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