FDA-Device2026-09-02Class IIPROCESSING DEFECT
FUJIFILM Synapse PACS software v7.4.310 recalled for inaccurate ruler measurements
What this means
FUJIFILM Synapse PACS software version 7.4.310, used in radiological imaging systems, has a software issue that can cause the ruler measurement tool to display inaccurate values. This affects 6 units distributed across select US states and Australia. No injuries have been reported.
- If you operate this system, verify you are using version 7.4.310 by checking your UDI or serial number against the list provided.
- Do not rely on ruler measurements from this software version for clinical decisions without independent verification.
- Contact FUJIFILM Healthcare Americas Corporation for a software update or corrective action.
The agency's original wording
Hazard
Software issue may cause the ruler measurement to be inaccurate.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Affected count
6 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3030-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.