Fujifilm Healthcare Americas recalls

Fujifilm Healthcare Americas appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• FUJIFILM Synapse PACS software v7.4.310
  FDA Device · Class II · 2026-09-02 · Fujifilm Healthcare Americas
• FDR Visionary Suite
  FDA Device · Class II · 2026-02-11 · Fujifilm Healthcare Americas
• FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
  FDA Device · Class II · 2025-10-15 · Fujifilm Healthcare Americas
• ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option…
  FDA Device · Class II · 2025-08-06 · Fujifilm Healthcare Americas
• Synapse PACS Software Version 7.4.x
  FDA Device · Class II · 2025-03-26 · Fujifilm Healthcare Americas
• The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital…
  FDA Device · Class II · 2024-10-02 · Fujifilm Healthcare Americas
• FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremi…
  FDA Device · Class II · 2024-06-05 · Fujifilm Healthcare Americas
• Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
  FDA Device · Class II · 2024-05-29 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.2.100
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.2.200
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.2.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.1.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.1.000US
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse PACS - Version 7.3.000
  FDA Device · Class II · 2024-03-13 · Fujifilm Healthcare Americas
• Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images
  FDA Device · Class II · 2024-02-28 · Fujifilm Healthcare Americas
• Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images
  FDA Device · Class II · 2024-02-28 · Fujifilm Healthcare Americas
• FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiograp…
  FDA Device · Class II · 2023-05-03 · Fujifilm Healthcare Americas
• SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
  FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas
• Surpria 64: Software Version V3.11, V3.22
  FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas
• Surpria: Software Version V3.11, V3.22
  FDA Device · Class II · 2022-09-21 · Fujifilm Healthcare Americas
• Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
  FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas
• Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
  FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas
• Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
  FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas
• Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
  FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas