HWR - BEUDAMED

Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Recall

Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·September 23, 2014

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 (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin clinical outcome has not been established. Manual Read of HER2 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 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin clinical outcome has not been established. ER/PR Image Analysis: The ScanScope XT 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 ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo

FDA Recall

Terminated ·Leica Biosystems Imaging, Inc.·Product code NOT·February 7, 2014

Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.

FDA Recall

Terminated ·Ohio Medical Corporation·Product code BTA·August 14, 2018

WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

FDA Recall

Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·February 16, 2009

VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2013

PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

FDA Recall

Terminated ·Leica Microsystems, Inc.·Product code HRM·September 25, 2017

JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.

FDA Recall

Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code MZA·May 6, 2013

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2013

1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2013

VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

FDA Recall

Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 6, 2013

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;

FDA Recall

Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·May 18, 2023