Fujifilm Healthcare Americas recalls

Fujifilm Healthcare Americas has 24 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 2 Sep 2026. 24 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls24since 2021
Last 12 months3reported
Class I00% of total
Ongoing24latest 2 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 24 100%Class III 0 0%

Why fujifilm healthcare americas is recalled

By year

Ongoing fujifilm healthcare americas recalls

24 active

All fujifilm healthcare americas recalls, newest first

24 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIFujifilm Synapse Pacs recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasLabeling ErrorsNationwide
DeviceCLASS IIFDR Visionary Suite recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasOtherNationwide
DeviceCLASS IIFDR Visionary Suite recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice Malfunction8 states
DeviceCLASS IIAsprire Cristalle Mammography System recalledFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice Malfunction30 states
DeviceCLASS IIThe device is a mobile x-ray system designed to work recalledFujifilm Healthcare AmericasOtherNationwide
DeviceCLASS IIFDR Visionary Suite - Intended to generate digital recalledFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IINoblus AC Adapter used with the Noblus Ultrasound Imaging System recalledFujifilm Healthcare AmericasOtherNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse PACS recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISynapse CV with AR recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasOtherNationwide
DeviceCLASS IISynapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0 recalledFujifilm Healthcare AmericasOtherNationwide
DeviceCLASS IIFujiFilm FDR AQRO recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISurpria: Software Version V3.11, V3.22 recalledFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IIScenaria View recalled by FUJIFILM Healthcare AmericasFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IISurpria 64: Software Version V3.11, V3.22 recalledFujifilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IIArietta 65 Ultrasound recalled by FujiFilm Healthcare AmericasFujiFilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IIArietta 750 Ultrasound recalled by FujiFilm Healthcare AmericasFujiFilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IILisendo 880 Ultrasound recalled by FujiFilm Healthcare AmericasFujiFilm Healthcare AmericasDevice MalfunctionNationwide
DeviceCLASS IIArietta 850 Ultrasound recalled by FujiFilm Healthcare AmericasFujiFilm Healthcare AmericasDevice MalfunctionNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.