FDA Device

Solar 9500 Information Monitor with software version 3A.

Hazard

Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.

What You Should Do

Remedy

A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated.

Products

Solar 9500 Information Monitor with software version 3A.
Brand
General Electric Medical Systems Information Technology
UPC
Solar 9500 Information Monitor with software version 3A.

Units Affected

maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)