MalfunctionIZH
AFFIRM PRONE BIOPSY SYSTEM, 3D
Received Jul 14, 2026 · Event occurred Jun 17, 2026
Report 3005496266-2026-00189 · MDR key 25812654
Device
Generic name
Breast Biopsy System
Manufacturer
Hologic, Inc.Model number
PBX-SYS-AFFIRM-3DCatalog number
PBX-SYS-AFFIRM-3D
Product problems
- Unintended System Motion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions