Recalls / —

—#81535

Product

GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

Affected lot / code info

All tables and serial numbers associated with Model Number 2271242.

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm

GE Medical Systems, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2009-03-12

Posted by FDA

2009-09-25

Terminated

2011-12-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #81535. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.