Philips MRI Elastography Safety Information R2611182

ANSM has formally recorded a field safety corrective action (FSCA) initiated by Philips involving MRI systems equipped with magnetic resonance elastography technology. The safety action is catalogued under ANSM reference number R2611182. Healthcare facilities and medical imaging centers operating these Philips MRI elastography systems should be aware that Philips has communicated directly with affected users and that a field safety corrective action is underway.

Facilities with Philips MRI elastography systems should monitor for incoming manufacturer communications, retain documentation of any actions taken in response to the Philips FSCA, and direct all questions regarding the corrective action to Philips as the issuing party. Compliance and clinical operations teams responsible for medical imaging equipment should verify whether their institution has received the Philips safety correspondence and ensure any required actions are implemented within any timelines specified by the manufacturer.