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 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.
The recall addresses potential stiffness value errors when viewing MR Elastography stiffness maps on PACS. This defect can lead to misinterpretation of patient data, which could affect diagnosis and treatment.
No specific incidents or injuries related to the stiffness errors have been reported at this time. However, the potential for misdiagnosis presents a serious concern.
Stop using the affected MR 7700 systems immediately. Contact Philips North America or your healthcare provider for further instructions and to follow recall procedures.
For more information, contact Philips North America at their official website or through customer service.
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