GE Medical Systems, LLC GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
All tables and serial numbers associated wtih Model Number 2225283.
Products Sold
All tables and serial numbers associated wtih Model Number 2225283.
GE Medical Systems, LLC is recalling GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi due to Failure to provide the certification label required by 21 CFR 1010.2.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to provide the certification label required by 21 CFR 1010.2.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026