FUJIFILM Healthcare Americas Corporation: Medical Device Recalls in 2025

According to to data from the FDA, there were 3 medical device recalls made by FUJIFILM Healthcare Americas Corporation in 2025. See the details of the recalls below.

You can see similar recalls for other firms.

• FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
• ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
• Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.