Philips North America recalled three MR systems on December 3, 2025. The recall affects models with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers and patients must stop using these devices immediately.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: Letter
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Philips MR systems are used for magnetic resonance imaging, providing detailed images of the human body. Healthcare providers often rely on this technology for accurate diagnoses and treatment plans.
The defect in the software can cause stiffness value errors in MR Elastography, compromising image quality and potentially leading to incorrect medical evaluations.
This recall is not part of a broader industry pattern.
The recall affects the reliability of medical imaging, which is crucial for patient diagnosis and treatment. Healthcare facilities must address this issue immediately to ensure patient safety.
The product codes and software versions are typically found on the device label or in the system settings menu.
Expect a response regarding the recall and potential refunds or replacements within 4-6 weeks.
Keep all correspondence regarding the recall, as well as any receipts or documentation of the device's purchase.
The recall involves MR systems with software versions R11.1 and R12.1, specifically product codes REF 782148 and REF 782116. Three units are affected, distributed across multiple states in the U.S. and countries including Canada, Germany, and the United Kingdom.
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