inforMED
MalfunctionPJA

HEARTFLOW ANALYSIS

Received Jul 8, 2026 · Event occurred Jun 12, 2026

Report 3021637148-2026-00007 · MDR key 25756356

Device

Generic name

Heartflow Analysis

Manufacturer

Heartflow, Inc.

Model number

4.X

Lot number

HFA_4.5.0.4

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions