RecallDepth

MAC-LAB 5000EX systems

This recall has been terminated (originally issued April 25, 2003).

Company
General Electric Medical Systems Information Technology
Recall Initiated
April 14, 2003
Posted
April 25, 2003
Terminated
June 24, 2004
Recall Number
Z-0785-03
Firm Location
Milwaukee, WI
Official Source
View on FDA website ↗

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.

Distribution

The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.

Lot / Code Info

The affected systems have serial numbers with XC and 4A as 3rd and 4th characters in the serial number

Root Cause

Other

Action Taken

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.

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