Company: General Electric Medical Systems Information Technology
Date of Enforcement Report: 1/21/04
Class: II
PRODUCT
Solar 9500 Information Monitor. Recall # Z-0250-04.
REASON
Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
CODE
Software version 3A.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter dated November 10, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Version. 3A software were manufactured plus 131 software update kits to update multiple).
DISTRIBUTION
Nationwide.