Recalls / —

—#96335

Product

HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

Affected lot / code info

With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.

Why it was recalled

A defect with the hardware and software displaying the incorrect dose data.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2010-02-01

Posted by FDA

2011-01-04

Terminated

2014-05-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #96335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.