Philips North America recalled 24 Ingenia 3.0T MR systems 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 across multiple states and countries. 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 recalled products are Ingenia 3.0T MR systems with product codes 781342 and 781377. They were sold in the United States and internationally in countries including Canada, France, and Germany. The recall involves 24 units.
The recall addresses potential stiffness value errors when viewing MR Elastography stiffness maps on Picture Archiving and Communication Systems (PACS). These errors pose a serious risk of misdiagnosis, potentially impacting patient care.
As of the recall date, there have been no reported injuries or deaths associated with the stiffness errors in these MR systems. The potential for misdiagnosis remains a concern.
Healthcare providers should stop using the recalled Ingenia 3.0T MR systems immediately. Follow the recall instructions provided by Philips North America and contact your healthcare provider for further guidance.
For assistance, contact Philips North America at their website or the FDA recall page. Additional information is also available through your healthcare provider.
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