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Terminated

GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM

FDA Recall Z-1044-2011 · Posted 2011-03-17

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMUE
Date Initiated2010-07-20
Date Terminated2012-05-16
Product Quantity112 total

Reason for Recall

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.

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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