—#97346

Product

GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer.

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: All associated serial numbers.

Why it was recalled

It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

An Important Electronic Product Radiation Warning letter was issued to customers identifying the affected product and describing the defect along with the related hazards. The letter states that there are no actions that are required to be taken on the part of the customer. A GE Healthcare Service Representative will apply the missing rating as necessary and free of charge. Questions or concerns regarding the letter should be directed to 1-800-437-1171 in the US.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2010-07-20
Posted by FDA: 2011-03-17
Terminated: 2012-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.