GE Medical Systems, LLC is recalling approximately 1,818 Senographe Pristina, Pristina Serena, and Pristina Serena 3D systems used for screening and diagnostic mammography. These systems were distributed with either a missing or an incorrect X-ray warning label, which does not meet federal safety regulations. Facility managers and healthcare providers should contact the manufacturer to arrange for the installation of the correct safety labels.
The incorrect or missing labels fail to provide the required safety warnings regarding X-ray radiation. This could lead to a misunderstanding of the device's operation or safety precautions, although the functional performance of the imaging system itself is not affected.
Quantity affected: 1,818 (1,580 US; 238 OUS). Systems are for screening and diagnostic mammography.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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