MAC-LAB 1000EX systems
FDA Recall Z-0783-03 · Posted 2003-04-25
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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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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