--- title: "FujiFilm Healthcare Americas Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search FujiFilm Healthcare Americas Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/fujifilm-healthcare-americas-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # FujiFilm Healthcare Americas Corporation recall records **24** reported ongoing 24 records in this archive. Latest source date Jul 22, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 22, 2026 FDA device enforcement ### [FUJIFILM Synapse PACS software v7.4.310; radiological image processing system](https://isitonrecall.com/recall/fda-device-z-3030-2026-fujifilm-synapse-pacs-software-v7-4-310-radiological-image-processing-system/) Software issue may cause the ruler measurement to be inaccurate. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia. [Official source for FUJIFILM Synapse PACS software v7.4.310; radiological image processing system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3030-2026%22) Jan 9, 2026 FDA device enforcement ### [FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)](https://isitonrecall.com/recall/fda-device-z-1299-2026-fdr-visionary-suite-model-number-ch-200-version-1-566-16130-23-2-566-16130-31-3/) It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. A... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI. [Official source for FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1299-2026%22) Sep 15, 2025 FDA device enforcement ### [FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33](https://isitonrecall.com/recall/fda-device-z-0044-2026-fdr-visionary-suite-ch-200-model-version-numbers-1-566-16130-23-2-566-16130-31-3-566-16130-33/) It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting. Class II Reported ongoing Distribution: Domestic: AK, CA, FL, IL, MA, NH, OH, WI. [Official source for FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0044-2026%22) Jun 11, 2025 FDA device enforcement ### [ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).](https://isitonrecall.com/recall/fda-device-z-2219-2025-asprire-cristalle-mammography-system-cleared-under-k212873-installed-with-the-aspire-cristalle-digit/) Devices had an unapproved slabbing software function enabled for use. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador. [Official source for ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2219-2025%22) Feb 11, 2025 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-1407-2025-synapse-pacs-software-version-7-4-x-software-versions-7-4-000-7-4-001-7-4-010-7-4-100-7-4-110-7-4-20/) The incorrect computed patient age is showing in VX for patients less than 3 months old. Class II Reported ongoing Distribution: Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, Fran... [Official source for Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1407-2025%22) Apr 11, 2024 FDA device enforcement ### [Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24](https://isitonrecall.com/recall/fda-device-z-1884-2024-noblus-ac-adapter-used-with-the-noblus-ultrasound-imaging-system-model-ahm250ps24/) AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable). Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1884-2024%22) Apr 11, 2024 FDA device enforcement ### [FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human an...](https://isitonrecall.com/recall/fda-device-z-1898-2024-fdr-visionary-suite-intended-to-generate-digital-or-conventional-radiographic-images-of-the-skull-sp/) Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury Class II Reported ongoing Distribution: US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI. [Official source for FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the sku...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1898-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.1.000](https://isitonrecall.com/recall/fda-device-z-1268-2024-synapse-pacs-version-7-1-000/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.1.000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1268-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.1.000US](https://isitonrecall.com/recall/fda-device-z-1269-2024-synapse-pacs-version-7-1-000us/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.1.000US](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1269-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.2.000](https://isitonrecall.com/recall/fda-device-z-1270-2024-synapse-pacs-version-7-2-000/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.2.000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1270-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.2.100](https://isitonrecall.com/recall/fda-device-z-1271-2024-synapse-pacs-version-7-2-100/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.2.100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1271-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.2.200](https://isitonrecall.com/recall/fda-device-z-1272-2024-synapse-pacs-version-7-2-200/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.2.200](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1272-2024%22) Jan 10, 2024 FDA device enforcement ### [Synapse PACS - Version 7.3.000](https://isitonrecall.com/recall/fda-device-z-1273-2024-synapse-pacs-version-7-3-000/) Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, ... [Official source for Synapse PACS - Version 7.3.000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1273-2024%22) Jan 3, 2024 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-1171-2024-synapse-cardiology-pacs-v7-3-0-v7-2-v7-1-v7-0-a-web-based-application-as-the-primary-user-interface/) The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting ... Class II Reported ongoing Distribution: US domestic distribution nationwide. International distribution to Israel. [Official source for Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user int...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1171-2024%22) Jan 3, 2024 FDA device enforcement ### [Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.](https://isitonrecall.com/recall/fda-device-z-1172-2024-synapse-cv-6-with-ar-a-web-based-application-as-the-primary-user-interface-for-the-processing-of-med/) The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting ... Class II Reported ongoing Distribution: US domestic distribution nationwide. International distribution to Israel. [Official source for Synapse CV 6. with AR. A web-based application as the primary user interface for the processing o...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1172-2024%22) Nov 23, 2023 FDA device enforcement ### [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 detectors coupled.](https://isitonrecall.com/recall/fda-device-z-3158-2024-the-device-is-a-mobile-x-ray-system-designed-to-work-with-fujifilm-s-gos-and-csi-scintillator-fdr-d/) When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the ... Class II Reported ongoing Distribution: US Nationwide and Worldwide [Official source for The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3158-2024%22) Feb 27, 2023 FDA device enforcement ### [FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including...](https://isitonrecall.com/recall/fda-device-z-1470-2023-fujifilm-fdr-aqro-model-dr-xd1000-a-digital-mobile-x-ray-system-intended-for-use-in-general-purpose/) Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general pu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1470-2023%22) Jul 12, 2022 FDA device enforcement ### [SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C](https://isitonrecall.com/recall/fda-device-z-1748-2022-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 will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct... Class II Reported ongoing Distribution: US Nationwide Distribution [Official source for SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1748-2022%22) Jul 12, 2022 FDA device enforcement ### [Surpria: Software Version V3.11, V3.22](https://isitonrecall.com/recall/fda-device-z-1749-2022-surpria-software-version-v3-11-v3-22/) Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct... Class II Reported ongoing Distribution: US Nationwide Distribution [Official source for Surpria: Software Version V3.11, V3.22](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1749-2022%22) Jul 12, 2022 FDA device enforcement ### [Surpria 64: Software Version V3.11, V3.22](https://isitonrecall.com/recall/fda-device-z-1750-2022-surpria-64-software-version-v3-11-v3-22/) Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruct... Class II Reported ongoing Distribution: US Nationwide Distribution [Official source for Surpria 64: Software Version V3.11, V3.22](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1750-2022%22) ## Reasons in these listed records - Software issue may cause the ruler measurement to be inaccurate. - It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it canno... - It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting. - Devices had an unapproved slabbing software function enabled for use. These examples come from this result page and are not a ranking of every recall reason. ## Checking FujiFilm Healthcare Americas Corporation ### Is there a recall on fujifilm healthcare americas corporation right now? This archive contains 24 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search FujiFilm Healthcare Americas Corporation](https://isitonrecall.com/check/?q=FujiFilm%20Healthcare%20Americas%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)