Philips North America recalled 9 MR 7700 systems on December 3, 2025, due to potential errors in stiffness maps. The recall affects models with software versions R11.1 and R12.1, posing a high hazard risk. Healthcare providers must stop using these devices immediately and follow manufacturer 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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The MR 7700 is a magnetic resonance imaging system used for medical imaging, particularly for assessing tissue stiffness through MR Elastography. Medical professionals purchase these systems to provide accurate diagnostic images and support patient care.
The stiffness value errors can lead to incorrect stiffness measurements in MR Elastography, potentially resulting in misdiagnosis or inappropriate treatment plans for patients.
This recall is not part of a broader industry pattern.
The recall impacts healthcare providers and patients relying on accurate imaging for diagnosis. Misinterpretation of stiffness values may lead to incorrect treatment decisions, highlighting the urgency for immediate action.
You can find the product code and serial numbers on the device's label or user manual.
Expect a timeline of 4-6 weeks for refund processing after submitting your recall request.
Keep a copy of the recall notice, all correspondence with the manufacturer, and any receipts or purchase records.
The recall involves 9 units of MR 7700 systems with software versions R11.1 and R12.1. Affected product codes include REF 782120 and REF 782153. These devices were distributed worldwide, including in states such as California, New York, and Texas.
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