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Terminated

GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

FDA Recall Z-1257-2009 · Posted 2009-09-25

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-03-12
Date Terminated2011-12-10
Product Quantity1179 total of all units

Reason for Recall

Failure to provide the certification label required by 21 CFR 1010.2.

Firm Action

A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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