FujiFilm Healthcare Americas Corporation
23 recalls on record · Latest: Feb 11, 2026
FujiFilm Healthcare Americas Corporation Recall Insight
FujiFilm Healthcare Americas Corporation appears on 23 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.023% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 23 entries, severity tagging shows 0 critical, 23 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 23 of 23 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (23). The date window on this page runs from Nov 10, 2021 to Feb 11, 2026.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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 …
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.
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 x-ray dete…
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and…
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Synapse PACS - Version 7.2.100
Synapse PACS - Version 7.1.000
Synapse PACS - Version 7.2.000
Synapse PACS - Version 7.1.000US
Synapse PACS - Version 7.3.000
Synapse PACS - Version 7.2.200
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.
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images…
Surpria 64: Software Version V3.11, V3.22
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Surpria: Software Version V3.11, V3.22
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
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Compare FujiFilm Healthcare Americas Corporation with Zimmer Biomet, Inc. →
Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.