Urgent Field Safety Notice For 3dimensions And Selenia Dimensions By Hologic, Inc Marlborough

Recall Summary Hologic, Inc. has issued an urgent field safety notice for 3Dimensions and Selenia Dimensions mammography devices distributed in Germany and the EU. The devices are classified as Class I, indicating a serious safety concern. The specific reason for the recall is not clearly detailed in the available information.

Recalling firm

Urgent Field Safety Notice for 3Dimensions and Selenia Dimensions by Hologic, Inc Marlborough , Download_Veroeffentlicht

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for 3Dimensions and Selenia Dimensions by Hologic, Inc Marlborough 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for 3Dimensions and Selenia Dimensions by Hologic, Inc Marlborough 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-04-15

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/7f3a8981-10a7-42bd-a0a8-7951d2868027