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Fujifilm Medical Systems U.S.A., Inc. - Aspire HD - Class 2 Recall
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - ASPIRE Cristalle - Class 2 Recall
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2018 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for t...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Assay for CA 27.29 - Class 2 Recall
Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for th...
Source: Medical Device Recalls - April 7, 2017 Category: Medical Equipment Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner (FDR1000BPY) - Class 2 Recall
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 31, 2016 Category: Medical Equipment Source Type: alerts

Dako North America Inc. - Dako HER2 CISH pharmDx Kit - Class 2 Recall
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Leica Biosystems Richmond Inc. - Class 3 Recall
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, ...
Source: Medical Device Recalls - June 11, 2016 Category: Medical Equipment Source Type: alerts

Skyla (levonorgestrel-releasing intrauterine system)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) April 2016 WARNINGS AND PRECAUTIONS Breast Cancer Observational studies of the risk of breast cancer with use of a LNG-releasing... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Fujifilm Medical Systems U.S.A., Inc. - Fujifilm Aspire HD, Full Field Digital, System - Class 2 Recall
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2015 Category: Medical Equipment Source Type: alerts

Carestream Health, Inc. - CARESTREAM DIRECTVIEW CR - Class 2 Recall
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2014 Category: Medical Equipment Source Type: alerts

Biogenex Laboratories, Inc. - InSite HER2/neu Detection Kit - Class 2 Recall
Insite HER-2: Detection Kit a semi-quantitative immunohistochemistry assay used to determine the overexpression of c-erbB-2 oncoprotein in patient breast cancer specimens. HRP/DAB Contents: 1 vial Power Block 1 Vial DAB Substrate Buffer 1 Vial DAB Chromogen 1 Vial Super Enhancer Reagent 1 Vial Her-2neu Antibody 1 Vial Poly-HRP Reagent 1 Vial Peroxide Block 1 Vial Hematoxylin 1 Vial Rabbit Negative Control 5 Positive control slides BioGenex, Fremont, CA 94538 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2014 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Hologic Selenia Full Field Digital Mammography System - Class 2 Recall
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2014 Category: Medical Equipment Source Type: alerts

Leica Biosystems Imaging, Inc. - ScanScope System - Class 2 Recall
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu ...
Source: Medical Device Recalls - March 8, 2014 Category: Medical Equipment Source Type: alerts

Dako North America Inc. - Dako HER2 CISH pharmDx(tm) kit - Class 2 Recall
Product Name: HER2 CISH pharmDx" Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated usin...
Source: Medical Device Recalls - February 27, 2014 Category: Medical Equipment Source Type: alerts

Hologic, Inc. - Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x - Class 2 Recall
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Senographe Essential System - Class 2 Recall
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2013 Category: Medical Equipment Source Type: alerts

U-systems Inc - Soma v Automated Breast Ultrasound System - Class 2 Recall
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 25, 2013 Category: Medical Equipment Source Type: alerts