FDA recall Z-3030-2026

FUJIFILM Healthcare Americas Corporation · Class II · device

Product

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

Reason for recall

Software issue may cause the ruler measurement to be inaccurate.

Distribution

Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.

Key facts

Status
Ongoing
Initiation date
2026-07-22
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3030-2026