Philips North America recalled one unit of its MR system on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed worldwide. Healthcare providers should stop using the device immediately and follow the manufacturer's 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 SmartPath to dStream is an MR system used for advanced imaging and diagnostics in medical settings. Healthcare providers purchase these systems for their ability to produce detailed images for evaluating patient conditions.
The defect causes potential stiffness value errors in exported MR Elastography maps, which are critical for accurate patient assessments. These inaccuracies can lead to incorrect diagnoses and treatment decisions.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who rely on this specific MR system for patient diagnostics, leading to potential delays in patient care.
Product codes and serial numbers are typically located on the back or side of the MR system.
Expect a refund or resolution within 4-6 weeks after following the recall instructions.
Keep records of all correspondence regarding the recall, including emails and letters, for your reference.
The recalled product is the SmartPath to dStream for 3.0T MR system, with product code REF 782145. The affected software versions are R11.1 and R12.1. This device was distributed in the U.S. and several countries, including Belgium and Canada.
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