GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: N/A
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The Senographe Pristina system is used for screening and diagnostic mammography, essential for early detection of breast cancer. Healthcare providers rely on its proper function for accurate patient assessments.
The missing or incorrect X-Ray Warning labels increase the risk of improper use, which can lead to dangerous exposure to radiation. This nonconformance to FDA regulations compromises patient safety.
This recall is not part of a broader industry pattern.
Consumers may face delays in screening services and potential health risks if the devices are used without proper labeling.
Model numbers and GTINs can typically be found on the device’s identification label or user manual.
Expect a realistic timeline of 4-8 weeks for processing refunds or replacements.
Keep copies of receipts, correspondence with the manufacturer, and any other relevant documentation regarding the recall.
The recall involves Senographe Pristina, Pristina Serena, and Pristina Serena 3D systems. A total of 1,818 units are affected, including 1,580 in the U.S. These systems were distributed in the U.S. and other countries.
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