AUDIENCE: Neurology, Risk Manager

ISSUE: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. For example, MR parameters such as voxel size (measurement of the image resolution or detail) and MR image acquisition time (e.g., up to 8 seconds) may contribute to inaccurate MR thermometry readings and potential errors in the ablation assessment. In addition, MRgLITT devices may not account for the continued thermal spread of energy to the surrounding tissue (as the target ablation area returns to its baseline temperature), which may result in an underestimation of thermal damage.

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OC Raw Dog, LLC of Rancho Santa Margarita, CA, is recalling approximately 1,560 lbs of Chicken, Fish & Produce Raw Frozen Canine Formulation which was manufactured on 10/11/2017 with a lot number 3652 and a use by date of 10/11/18. We are voluntarily recalling because of potential contamination with Listeria monocytogenes, which can cause severe and potentially fatal infection in animals consuming the pet food, and the humans that handle the pet food and surfaces exposed to the product.

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Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling one lot of Sunseed Vita Prima Exotics Sugar Glider Formula because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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R.J. Reynolds Vapor Company has voluntarily initiated a nationwide safety recall of all Vuse Vibe power units. The Company initiated the recall after receiving consumer complaints about malfunctioning batteries, which may cause the power unit to overheat and create a fire risk. The Company notified the U.S. Food and Drug Administration regarding the issue and will be working directly with the Agency on this voluntary recall.

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Seacrest Foods International, Inc. of Lynn, MA is voluntarily recalling 29 cases of Formagere de la Brie brand, l’Explorateur soft ripened cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages, stillbirths and fetal infection among pregnant women.

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K9 Natural Ltd is voluntarily recalling four batches of the K9 Natural Frozen Chicken Feast 2.2lb and 11lb bags that was imported into the US market in June 2017 because they have the potential to be contaminated with Listeria Monocytogenes.

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