Philips North America recalled six MR systems on December 3, 2025. The recall affects devices with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers must stop using the affected units 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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The Ingenia 3.0T CX MR system is a medical imaging device primarily used for non-invasive diagnostics. Healthcare providers use it to assess various medical conditions through advanced imaging technology.
The hazard arises from potential stiffness value errors when exporting MR Elastography stiffness maps to Picture Archiving and Communication Systems. These errors can lead to incorrect diagnoses and treatment decisions.
This recall is not part of a broader industry pattern.
This recall may affect healthcare providers' ability to accurately diagnose patients, potentially leading to delays in treatment or incorrect medical interventions.
The product code and serial numbers can typically be found on the device's main label or user manual.
Expect a timeline of 4-6 weeks for the processing of refunds or replacements.
Keep records of all communications with Philips, including emails and receipts related to the purchase of the MR system.
The recalled product is the Ingenia 3.0T CX MR system, Product Code (REF): 781271. The affected software versions are R11.1 and R12.1. The systems were distributed worldwide, including various states in the U.S. and countries such as Canada, Germany, and Japan.
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