PlainRecalls

FUJIFILM Healthcare Americas Corporation

15 recalls on record · Latest: Feb 11, 2026

FUJIFILM Healthcare Americas Corporation Recall Insight

FUJIFILM Healthcare Americas Corporation appears on 15 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.018% 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 15 entries, severity tagging shows 0 critical, 15 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 15 of 15 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 (15). 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.

FDA Devices Moderate Feb 11, 2026

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

FDA Devices Moderate Aug 6, 2025

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved …

FDA Devices Moderate Oct 2, 2024

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…

FDA Devices Moderate Jun 5, 2024

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and…

FDA Devices Moderate Mar 13, 2024

Synapse PACS - Version 7.2.100

FDA Devices Moderate Mar 13, 2024

Synapse PACS - Version 7.1.000

FDA Devices Moderate Mar 13, 2024

Synapse PACS - Version 7.2.000

FDA Devices Moderate Mar 13, 2024

Synapse PACS - Version 7.1.000US

FDA Devices Moderate Mar 13, 2024

Synapse PACS - Version 7.3.000

FDA Devices Moderate Feb 28, 2024

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.

FDA Devices Moderate Feb 28, 2024

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

FDA Devices Moderate Sep 21, 2022

Surpria 64: Software Version V3.11, V3.22

FDA Devices Moderate Sep 21, 2022

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

FDA Devices Moderate Nov 10, 2021

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

FDA Devices Moderate Nov 10, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare FUJIFILM Healthcare Americas Corporation with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds