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Fujifilm Healthcare Americas Corporation Recalls

13 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fujifilm Healthcare Americas Corporation.

13Total Recalls
0Critical
527Units Affected
Jan 9, 2026Most Recent
All Recalls

Every Fujifilm Healthcare Americas Corporation Recall

Sorted by most recent. Click any recall for full details.

13 recalls
High RiskFDA
Fujifilm Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Medical Devices·16 affected·Jan 9, 2026
High RiskFDA
Fujifilm Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Optio...
Medical Devices·293 affected·Jun 11, 2025
High RiskFDA
Fujifilm Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extr...
Medical Devices·18 affected·Apr 11, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse PACS - Version 7.2.100
Medical Devices·35 affected·Jan 10, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse PACS - Version 7.1.000
Medical Devices·22 affected·Jan 10, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse PACS - Version 7.2.000
Medical Devices·19 affected·Jan 10, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse PACS - Version 7.1.000US
Medical Devices·3 affected·Jan 10, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
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 i...
Medical Devices·13 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Medical Devices·8 affected·Jan 3, 2024
High RiskFDA
Fujifilm Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Medical Devices·16 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Medical Devices·46 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices·38 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices·0 affected·Oct 14, 2021