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 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.
Some Senographe Pristina systems have missing or incorrect X-Ray Warning labels. This violates FDA Regulation 21 CFR 1020.30(j), potentially leading to misuse and increased radiation exposure.
No specific incidents or injuries have been reported related to this recall. The absence of proper warning labels may lead to serious safety concerns.
Patients and healthcare providers must stop using the affected devices immediately. Contact GE Medical Systems, LLC or your healthcare provider for further instructions.
For more information, reach GE Medical Systems at their official website or consult your healthcare provider. Further details are available at the FDA recall page.
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