Hologic Mammographe RX 3Dimensions and Selenia Dimensions Safety Notice

ANSM registered a safety action by Hologic Inc. under reference R2609345 for Mammographe RX 3Dimensions and Selenia Dimensions mammography devices. The notification does not specify the nature of the safety defect or the required corrective measures in the visible text. Healthcare facilities and medical imaging centers using these Hologic mammography systems should locate and review the manufacturer's letter dated 20 April 2026 for specific instructions on patient safety, device use, or scheduling of service interventions.

Facilities that may have received the Hologic communication should file it with their medical device service records and confirm receipt if not yet received. Since the recall details are contained in the attached manufacturer letter rather than the ANSM notice itself, device managers should obtain the full PDF to determine applicable actions.