Recall Z-3030-2026— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-3030-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22. It names one FDA 510(k) clearance: K190232. Product: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system. Reason: Software issue may cause the ruler measurement to be inaccurate..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-07-22
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K190232 — Synapse PACSFujifilm Corporation·cleared 2019-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

Reason for recall

Software issue may cause the ruler measurement to be inaccurate.

Data sourced from openFDA. This site is unofficial and independent of the FDA.