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
Read the official notice →- Date
- 2024-06-05
- Country
- United States
- Brand
- FUJIFILM Healthcare Americas
- Product
- FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-08-06
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…
- 2024-05-29
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 →
Other drugs & medical recalls in the United States
- 2024-06-05
US
Stryker Neurovascular recalls Trevo ProVue, Catalog: 90184
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of MN, PA, IL,…Official notice →US
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA · DeviceSmith & Nephew IncInternational distribution to the countries of Australia, Germany, Japan,…Official notice →US
Lucid Diagnostics, Inc. recalls Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A…
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper…
FDA · DeviceLucid Diagnostics, Inc.US Nationwide distribution in the states of MN, MD.Official notice →US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: OK International: India, Spain, U.A.E.Official notice →US
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
FDA · DeviceMirion Technologies (Capintec), Inc.Worldwide - US Nationwide distribution and the countries of ALGERIA,…Official notice →US
Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,…
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
FDA · DeviceCovidien, LPWorldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice →