GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
FDA device recall Z-1257-2009 · posted 2009-09-25 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Failure to provide the certification label required by 21 CFR 1010.2.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1179 total of all units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-12
- Date posted
- 2009-09-25
- Date terminated
- 2011-12-10
- Location
- Waukesha, WI
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