GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
FDA Recall Z-1258-2009 · 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.