FUJIFILM Healthcare Americas recalls
14 official recalls and safety alerts involving FUJIFILM Healthcare Americas since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with FUJIFILM Healthcare Americas or the relevant agency.
- 2026-09-02
USFUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Software issue may cause the ruler measurement to be inaccurate.
FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH,…Official notice →- 2026-02-11
- US
FUJIFILM Healthcare Americas Corporation recalls 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…
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, CT, FL, IL, NH, OH, WI.Official notice → - 2025-10-15
- US
FUJIFILM Healthcare Americas Corporation recalls 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…
FDA · DeviceFUJIFILM Healthcare Americas CorporationDomestic: AK, CA, FL, IL, MA, NH, OH, WI.Official notice → - 2025-08-06
- US
FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Devices had an unapproved slabbing software function enabled for use.
FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2025-03-26
- US
FUJIFILM Healthcare Americas Corporation recalls 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 incorrect computed patient age is showing in VX for patients less than 3 months old.
FDA · DeviceFUJIFILM Healthcare Americas CorporationDomestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS,…Official notice → - 2024-10-02
- US
FUJIFILM Healthcare Americas Corporation recalls The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID)…
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…
- 2024-06-05
- US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.Official notice → - 2024-05-29
- US
FUJIFILM Healthcare Americas Corporation recalls 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).
- 2024-03-13
- US
FUJIFILM Healthcare Americas Corporation recalls 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.
FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2024-02-28
- US
FUJIFILM Healthcare Americas Corporation recalls Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the…
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…
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS domestic distribution nationwide. International distribution to Israel.Official notice → - 2023-05-03
- US
FUJIFILM Healthcare Americas Corporation recalls FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for…
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.
- 2022-09-21
- US
FUJIFILM Healthcare Americas Corporation recalls 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…
- 2021-11-10
- US
FujiFilm Healthcare Americas Corporation recalls Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow…
- US
FujiFilm Healthcare Americas Corporation recalls Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement…