Class 2 Device Recall Solar

• Date Initiated by Firm: November 10, 2003
• Date Posted: December 18, 2003
• Recall Status: Terminated 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/ Manufacturer: General Electric Medical Systems Information Technology; 8200 W Tower Ave; Milwaukee WI 53223-3219
• For Additional Information Contact: Paul Hanneman; 414-362-2402
• 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: Other
• 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