FUJIFILM Healthcare Americas Corporation recalls
Every recall we track for FUJIFILM Healthcare Americas Corporation — 24 in all, from 2021–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from FUJIFILM Healthcare Americas Corporation fell by more than half in 2025 (3, down from 10 in 2024). 4% rated “stop using now”.
All FDA recall records for FUJIFILM Healthcare Americas Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 3 | 0 | 4 |
| 2022 | 0 | 1 | 2 | 0 | 3 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 1 | 3 | 5 | 1 | 10 |
| 2025 | 0 | 1 | 2 | 0 | 3 |
| 2026 (to date) | 0 | 1 | 1 | 0 | 2 |
What to do if you have a recalled FUJIFILM Healthcare Americas Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All FUJIFILM Healthcare Americas Corporation recalls
14 shown- Lower riskMedical device
FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FUJIFILM recalls software version v7.4.310 for inaccurate ruler measurements in radiological image processing systems. Affected units include specific serial numbers and UDI codes.
FUJIFILMJul 22, 2026 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FUJIFILM Healthcare recalls specific models of X-ray high-voltage generators (CH-200) due to risk of overheating and smoke after power cut. Affected units have unique serial numbers and versions.
FUJIFILM HealthcareJan 9, 2026 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare recalls CH-200 X-ray units with specific model numbers due to risk of X-ray tube shaft breaking during operation, potentially causing injury. Affected units include model versions 566-16130-23, 566-16130-31, and 566-16130-33.
FUJIFILM HealthcareSep 15, 2025 - Lower riskMedical device
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast
FUJIFILM Healthcare recalls ASPRIRE Cristalle Mammography Systems with unapproved slabbing software. Affected units have specific model numbers and UDI codes. No remedy provided in official notice.
FUJIFILM HealthcareJun 11, 2025 - Lower riskMedical device
FUJIFILM Healthcare Americas Corporation recalls 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.
FUJIFILM recalls Synapse PACS software versions 7.4.000-7.4.200 due to incorrect patient age calculations for infants under 3 months old. Affected users should verify their software version.
FUJIFILM HealthcareFeb 11, 2025 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FUJIFILM Healthcare recalls Noblus AC adapters for ultrasound systems that may overheat and cause smoke if power cables are frequently plugged in and out.
FUJIFILM HealthcareApr 11, 2024 - Stop using nowMedical device
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,
FUJIFILM recalls specific FDR Visionary Suite models for potential tube rupture causing patient injury during skull or spine imaging. Affected units have unique serial numbers and model numbers listed in the recall notice.
FUJIFILM HealthcareApr 11, 2024 - Lower riskMedical device
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.100
FUJIFILM Healthcare recalls Synapse PACS software version 7.2.100 due to potential incorrect breast cancer measurements when used with specific imaging. Affected users should contact the company for updates.
FUJIFILM HealthcareJan 10, 2024 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the
FUJIFILM Healthcare recalls specific versions of Synapse Cardiology PACS software due to potential incorrect left ventricle mass calculations, which could lead to misdiagnosis or incorrect treatment.
FUJIFILM HealthcareJan 3, 2024 - Lower riskMedical device
FUJIFILM Healthcare Americas Corporation recalls The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID)
FUJIFILM Healthcare recalls mobile x-ray systems with default adult chest exposure settings that may cause incorrect imaging. Affected units have specific serial numbers from all shipments.
FUJIFILM HealthcareNov 23, 2023 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for
FujiFilm recalls digital mobile X-ray systems (DR-XD1000) due to risk of serious injury from a breakable arm component. Affected units have serial numbers ending 0001-1993. Contact for repair or return.
FUJIFILM HealthcareFeb 27, 2023 - Use cautionMedical device
FUJIFILM Healthcare Americas Corporation recalls Surpria 64: Software Version V3.11, V3.22
FUJIFILM recalls Surpria 64 software versions V3.11 and V3.22 due to potential radiation exposure from improper image reconstruction during scans. Affected units may require additional scans.
FUJIFILM HealthcareJul 12, 2022 - Lower riskMedical device
FujiFilm Healthcare Americas Corporation recalls Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FujiFilm recalls Arietta 65 ultrasound software versions V1.0 through V4.0.0 due to incorrect calculation of Effective Regurgitant Orifice Area (EROA) when used with Fujifilm transducers, potentially leading to inaccurate heart flow measurements.
FujiFilmOct 14, 2021 - Use cautionMedical device
FujiFilm Healthcare Americas Corporation recalls Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Recalled FujiFilm Arietta 850 ultrasound systems with specific software versions (V1.0.0 to V4.1.3) may show incorrect mitral regurgitation and valve measurements, risking inaccurate cardiac diagnoses.
FujiFilmOct 14, 2021
FUJIFILM Healthcare Americas Corporation recall questions
How many recalls has FUJIFILM Healthcare Americas Corporation had?
24 recalls from FUJIFILM Healthcare Americas Corporation are on record with U.S. safety agencies, from 2021–2026.
What is the most recent FUJIFILM Healthcare Americas Corporation recall?
FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310; radiological image processing system, dated Jul 22, 2026. Every FUJIFILM Healthcare Americas Corporation recall is listed on this page, newest first.
What should I do if I have a recalled FUJIFILM Healthcare Americas Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new FUJIFILM Healthcare Americas Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.