inforMED
MalfunctionIZH

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Received Jul 10, 2026 · Event occurred Jun 11, 2026

Report 3005496266-2026-00182 · MDR key 25786990

Device

Generic name

System, X-ray, Mammographic

Manufacturer

Hologic, Inc

Model number

STLC-00004

Catalog number

STLC-00004

Product problems

  • Unintended Movement

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions