—#97538

Product

GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.

FDA product code: RCE — Cabinet X-Ray, Industrial
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: Part Number 5134163.

Why it was recalled

Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2011-01-31
Posted by FDA: 2012-02-17
Terminated: 2012-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.