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Terminated

MAC-LAB 5000EX systems

FDA Recall Z-0785-03 · Posted 2003-04-25

Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeKMI
Date Initiated2003-04-14
Date Terminated2004-06-24

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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