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.
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.
Recalling Firm:
General Electric Medical Systems, Information Technologies
8200 West Tower Avenue
Milwaukee, WI 53223
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.
