• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

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
Solar 9500 Physiological ECG Monitor
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.