—#86802

Product

Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: All serial numbers associated with model numbers H3000WC and H3000WD.

Why it was recalled

Failure to provide the complete User Manual information.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-08-01
Posted by FDA: 2010-01-21
Terminated: 2012-02-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86802. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.