Philips North America recalled 24 Ingenia 3.0T MR systems on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed across multiple states and countries. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.
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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The Ingenia 3.0T MR system is a magnetic resonance imaging device used in hospitals and clinics to create detailed images of the body. Healthcare providers rely on these systems for accurate diagnostics and treatment planning.
The recall addresses potential errors in stiffness value readings from MR Elastography maps, which can lead to incorrect assessments of tissue conditions. This risk underlines the importance of accurate imaging in medical diagnostics.
This recall is not part of a broader industry pattern.
The recall may result in temporary disruptions in diagnostic services for healthcare providers using the affected MR systems. This could impact patient care and necessitate alternative imaging solutions in the interim.
Product codes and serial numbers can usually be found on the device's information label or in the device's user manual.
Expect a timeline of approximately 4 to 6 weeks for refund processing after following the recall instructions.
Keep records of your MR system's product code, serial number, and any correspondence related to the recall for future reference.
The recalled products are Ingenia 3.0T MR systems with product codes 781342 and 781377. They were sold in the United States and internationally in countries including Canada, France, and Germany. The recall involves 24 units.
Not sure what to do next? Our guide walks you through the process step by step.
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