Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices immediately and follow recall instructions.
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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MR systems are used in medical imaging to assess tissue stiffness, which can help diagnose conditions. Healthcare providers rely on accurate imaging for patient care, making these systems essential in clinical settings.
The defect in these MR systems can lead to stiffness value errors, which could mislead healthcare professionals when interpreting patient data. This can result in incorrect diagnoses or treatment plans.
This recall is not part of a broader industry pattern.
The recall affects a small number of units but poses significant risks in clinical settings where accurate diagnostic imaging is critical.
You can find the product code and serial number on the back or underside of the MR system.
Expect a refund or replacement processing time of approximately 4-8 weeks.
Keep copies of any notifications received, correspondence with the manufacturer, and photographs of the affected device.
The recall affects MR systems with software versions R11.1 and R12.1 and product code REF 782130. These devices were distributed worldwide, including states like Arizona, California, and New York, as well as countries such as Canada, Germany, and Japan.
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