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U.S. Department of Health and Human Services

Class 2 Device Recall MACLAB

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  Class 2 Device Recall MACLAB see related information
Date Initiated by Firm April 14, 2003
Date Posted April 25, 2003
Recall Status1 Terminated 3 on June 24, 2004
Recall Number Z-0785-03
Recall Event ID 25951
Product Classification Monitor, Bed Patient - Product Code KMI
Product MAC-LAB 5000EX 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 2		 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.
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