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…
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- FUJIFILM Healthcare Americas
- Product
- 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…
- Classification
- Class II
- Units
- US Nationwide and Worldwide
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More FUJIFILM Healthcare Americas recalls
- 2025-10-15
USFUJIFILM 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 → - 2024-06-05
- 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 →
Other drugs & medical recalls in the United States
- 2024-10-02
- US
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - US
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - US
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
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Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management…
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
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Datascope Corp. recalls CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice → - US
Datascope Corp. recalls CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and…
FDA · DeviceDatascope Corp.International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA…Official notice →