Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 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 1.5T MR system is used for medical imaging, particularly MR Elastography, to evaluate tissue stiffness. Healthcare providers use this equipment to diagnose various conditions based on stiffness measurements.
The defect can lead to stiffness value errors in imaging results, which may mislead healthcare providers and affect patient diagnoses. This could potentially compromise patient safety if misinterpretations occur.
This recall is not part of a broader industry pattern.
The recall can disrupt imaging services and requires immediate action by healthcare providers, potentially delaying patient diagnoses.
Serial numbers can typically be found on the device's identification plate or in the device's user manual.
Expect 4-8 weeks for refund or replacement processing after submission of recall instructions.
Keep a record of all communications, receipts, and any relevant documents regarding the recall.
The recall affects Ingenia 1.5T MR systems with Product Codes (REF): 781341 and 781396. These systems were distributed worldwide, including multiple U.S. states and countries such as Canada and Germany. The systems were sold as part of standard medical imaging equipment.
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