Class 2 Device Recall MACLAB

• Date Initiated by Firm: April 14, 2003
• Date Posted: April 25, 2003
• Recall Status: Terminated on June 24, 2004
• Recall Number: Z-0786-03
• Recall Event ID: 25951
• Product Classification: Monitor, Bed Patient - Product Code KMI
• Product: MAC-LAB (Classic) systems
• Code Information: The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number
• Recalling Firm/ Manufacturer: General Electric Medical Systems Information Technology; 8200 W. Tower; Milwaukee WI 53223
• Manufacturer Reason for Recall: There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
• FDA Determined Cause: Other
• Action: A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.
• Distribution: The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located 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.