FUJIFILM Healthcare Americas Corporation

Complete recall history across all FDA and CPSC categories — 23 total recalls

FUJIFILM Healthcare Americas Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (23)

FDA medical device enforcement actions by FUJIFILM Healthcare Americas Corporation

Date Product Reason Class
Jan 9, 2026 FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 5... It was found that the contacts of the electromagnetic contactors used inside ... Class II
Sep 15, 2025 FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... It was found that the shaft for mounting the X-ray tube unit on the support m... Class II
Jun 11, 2025 ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... Devices had an unapproved slabbing software function enabled for use. Class II
Feb 11, 2025 Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... The incorrect computed patient age is showing in VX for patients less than 3 ... Class II
Apr 11, 2024 Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... AC adapters of Noblus can heat up, and cause smoke in the worst case, when an... Class II
Apr 11, 2024 FDR Visionary Suite - Intended to generate digital or conventional radiograph... Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube... Class II
Jan 10, 2024 Synapse PACS - Version 7.2.200 Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 10, 2024 Synapse PACS - Version 7.3.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 10, 2024 Synapse PACS - Version 7.1.000US Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 10, 2024 Synapse PACS - Version 7.2.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 10, 2024 Synapse PACS - Version 7.1.000 Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 10, 2024 Synapse PACS - Version 7.2.100 Measurements on a Secondary Capture 2D image, that does not have pixel spacin... Class II
Jan 3, 2024 Synapse CV 6. with AR. A web-based application as the primary user interfa... The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in ... Class II
Jan 3, 2024 Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in ... Class II
Nov 23, 2023 The device is a mobile x-ray system designed to work with Fujifilm's GOS and ... When the key switch is turned on, the exposure conditions are set to the defa... Class II
Feb 27, 2023 FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended f... Arm which holds the tube head in place is susceptible to breaking, if the dev... Class II
Jul 12, 2022 Surpria: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images wi... Class II
Jul 12, 2022 SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Error 00003050 or 00003052 may occur during scanning, the captured images wi... Class II
Jul 12, 2022 Surpria 64: Software Version V3.11, V3.22 Error 00003050 or 00003052 may occur during scanning, the captured images wi... Class II
Oct 14, 2021 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 When the ultrasound system is used in combination with a Fujifilm (formally H... Class II
Oct 14, 2021 Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Diagnostic ultrasound system with the specified software version and used in ... Class II
Oct 14, 2021 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in ... Class II
Oct 14, 2021 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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