FDA recall record · openFDA

FUJIFILM Healthcare Americas Corporation

16 FDA recalls on record (2023–2026) — 16 device. 16 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a 6

The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricl 2

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage gener 1

Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient i 1

Devices had an unapproved slabbing software function enabled for use. 1

Recalls

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) Class II 2026-01-09 ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt Class II 2025-06-11 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. Class II 2025-02-11 FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 Class II 2025-09-15 Synapse PACS - Version 7.2.100 Class II 2024-01-10 Synapse PACS - Version 7.1.000 Class II 2024-01-10 Synapse PACS - Version 7.2.000 Class II 2024-01-10 Synapse PACS - Version 7.1.000US Class II 2024-01-10 Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces Class II 2024-01-03 FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che Class II 2024-04-11 Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images. Class II 2024-01-03 Synapse PACS - Version 7.3.000 Class II 2024-01-10 Synapse PACS - Version 7.2.200 Class II 2024-01-10 Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 Class II 2024-04-11 The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) Class II 2023-11-23 FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g Class II 2023-02-27

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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