—#94928

Product

BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2.

Why it was recalled

Failure to properly document the CTDI in the Technical Reference or User Manual.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-05-01
Posted by FDA: 2011-03-01
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.