The Boston Scientific LIVIAN, COGNIS, and CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT).

The KODAK DirectView CR Mammography System consists of the KODAK DirectView CR Mammography Cassette with EHR-M Screen designed to fit into the Bucky device of standard mammography x-ray equipment, and the KODAK DirectView CR Mammography Feature Software..

These medical products are contained in sterile pouches that have weak or open seals. These products could become or have been contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death.

HER2 FISH pharmDx? is a laboratory test that uses DNA probes with fluorescent dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample.

HercepTest is a laboratory test that measures how much Her2 protein is being made by the cancer cells. This test has been used in patients with breast cancer and now can be used in patients with spreading (metastatic) stomach (gastric) cancer.

The EC-3 Posterior Chamber IOLs (Models EC-3 and EC-3 PAL) are artificial lenses used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of...

These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

VITEK 2 Gram Negative Susceptibility Cards that contain Piperacillin/Tazobactam are reporting incorrect results for testing the susceptibility of E. coli and K. pneumoniae to this drug.

The Symbiq One and Two-Channel Infusers are infusion pumps intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural...

This device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity.