Philips North America recalled 31 MRI systems on December 3, 2025, due to potential errors in stiffness value readings. The affected models include product codes 781358, 782107, and 782136 with software versions R11.1 and R12.1. 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 Elition X MRI system is used for medical imaging to provide detailed images of the body. Healthcare providers rely on accurate readings from these systems for diagnosis and treatment planning.
The recall addresses stiffness value errors in MR Elastography, which can lead to incorrect interpretations of tissue properties. These errors can directly impact patient care and treatment outcomes.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease use of the affected MRI systems immediately to avoid potential misdiagnosis, which could have serious implications for patient health.
Serial numbers and product codes can typically be found on the device's label or user manual.
Expect a response from Philips North America within 4-6 weeks regarding the recall process and any potential refunds.
Keep records of all communications regarding the recall, including letters from Philips and any correspondence with healthcare providers.
The recall affects 31 units of the Ingenia Elition X MRI systems with software versions R11.1 and R12.1. The specific product codes are 781358, 782107, and 782136. These systems were distributed worldwide, including in 15 US states and multiple countries.
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