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U.S. Department of Health and Human Services

Class 2 Device Recall Solar

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  Class 2 Device Recall Solar see related information
Date Initiated by Firm November 10, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on November 23, 2005
Recall Number Z-0250-04
Recall Event ID 27811
510(K)Number K030575  
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
Product Solar 9500 Information Monitor with software version 3A.
Code Information Solar 9500 Information Monitor with software version 3A.
Recalling Firm/
General Electric Medical Systems Information Technology
8200 W Tower Ave
Milwaukee WI 53223-3219
For Additional Information Contact Paul Hanneman
Manufacturer Reason
for Recall
Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
FDA Determined
Cause 2
Action 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.
Quantity in Commerce maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)
Distribution The product was distributed to consignees located nationwide in the United States and worldwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES