HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)

FDA device recall Z-0781-2011 · posted 2011-01-04 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAK

Quantity affected

102 total

Distribution

Nationwide Distribution

Date initiated

2010-02-01

Date posted

2011-01-04

Date terminated

2014-05-21

Location

Waukesha, WI