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U.S. Department of Health and Human Services

Medical Devices

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Solar 9500 Physiological ECG Monitor

Class I Recall

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 Medical Device Recalls Page.

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:
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:
Mr. Mark Stauffer
Quality Assurance Manager
Phone: 414-362-2703
FDA District:
Minneapolis District Office
FDA Comment:
Until correct computer chips are installed in these monitors FDA considers there to be a life threatening risk from use of this product.