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 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.
The recall addresses potential stiffness value errors when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems (PACS). These errors can lead to misinterpretation of patient conditions.
There are no reported incidents or injuries associated with this recall. The hazard level is classified as high.
Patients and healthcare providers should stop using the MR system immediately. Contact Philips North America for further instructions and to follow the recall process.
For more details, contact Philips North America at the provided recall instructions. Information is also available on the FDA website.
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