HOLOGIC INC

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Hologic Selenia Dimensions 6000 package for 2D screening and diagnostic mammography. Upgradable to interventional or mobile.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.

The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system

Selenia® Dimensions® digital mammography system

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® compression paddles provide an optically and radiographically transparent surface to immobolize and flatten the patient breast, ensuring the highest possible image quality with minimum patient discomfort.

Selenia® Dimensions® digital mammography system

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