Volkswagen Recalls 2012-2014 Passat to Replace Driveshaft Heat Shield

just-auto global news

May 31, 2017

NHTSA campaign No.: 17V309000. Manufacturer: Volkswagen Group of America. Components: Engine and engine cooling, power train. Potential number of units affected: 84,262.


Summary: Volkswagen Group of America (Volkswagen) is recalling certain 2012-2014 Passat vehicles, equipped with diesel engines and Direct-Shift Transmission. The vehicles underbody heat shield may not be long enough to protect the right half-shaft grease boot from heat, potentially resulting in a grease leak. If the leaking grease contacts a heated surface, such as the exhaust system and/or the diesel particulate filter, it could increase the risk of fire.


Remedy: Volkswagen will notify owners, and dealers will replace the driveshaft heat shield, free of charge. The recall is expected to begin in July 2017. Owners may contact Volkswagen customer service at 1-800-893-5298. Volkswagens number for this recall is 23W5.


Original headline: VWoA recalls 2012-2014 Passat to replace the driveshaft heat shield


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FDA Assembles Team to Oversee AI Revolution in Health

Pharma & Healthcare Monitor Worldwide

May 31, 2017

Mobile health apps and wearable devices that use artificial intelligence (AI) to help diagnose or even treat medical conditions pose a new regulatory challenge for the U.S. Food and Drug Administration (FDA). The government agency has responded by starting to assemble a team of computer scientists and engineers to help oversee and anticipate future developments in AI-driven medical software.


This comes at a time when medical devices have evolved from fairly self-contained gadgets into implants and wearables that communicate wirelessly with medical software on separate computers or in the cloud. The definition of medical device has also stretched as smartphone apps and online services often backed by machine-learning algorithms promise to deliver medical diagnoses that once would have required a visit to a doctors office and specialized lab equipment. That is why the FDA aims to create a new digital health unit around people having both the technical expertise and industry experience to understand how machine-learning AI and related subjects such as big data, cybersecurity and cloud computing will all affect health care for Americans.


Were trying to get people who have hands-on development experience with a products full life cycle, says Bakul Patel, the FDAs associate director for digital health. We already have some scientists who know artificial intelligence and machine learning, but we want complementary people who can look forward and see how this technology will evolve.


The FDA has already spent years working with the medical devices industry and issuing guidance to clarify what products and services require more strict regulation. For example, the past decade has witnessed an explosion of health and wellness apps for smartphone users to download. But the FDA does not regulate most of those apps as long as they pose relatively low risk to the public, even if the health and wellness claims of such apps may be unjustified.


Examples of apps that may meet the FDAs definition of medical device but do not necessarily require the attention of regulators include: apps that help sufferers of psychiatric conditions such as depression and anxiety with behavioral techniques or audio messages; apps that help asthmatics track inhaler usage, asthma episodes or environmental triggers of asthma attacks; and apps that provide information about interactions between different drugs or keep track of medications being taken.


The new digital health unit will not change the FDAs relatively hands-off attitude toward the majority of mobile health and wellness apps. But certain apps and other software designed to diagnose serious medical conditions or guide treatment would likely earn the attention of the digital health unit and FDA reviewers. For example, machine-learning algorithms that could help diagnose cervical cancer or possibly predict heart attacks would fall under this category.


When you start adding analytical AI for any image analysisthink of detecting cancer or some other serious diseaseat that point people need to know when that detection means something and is real, Patel says.


Last fall, the FDA and industry finalized a new medical device user fee agreement that lays out the application process and expectations regarding medical devices being submitted for regulatory approval. That agreement includes mention of the new digital health unit and its responsibilities such as providing technical assistance to FDA reviewers overseeing new medical software submissions and coordinating digital health initiatives across the agency.


The digital health unit must also ensure that the regulatory process can accommodate the rapid and iterative process of software updates commonly used to improve existing products and services. And its responsible for ensuring that the FDAs regulations generally seem consistent with the work of regulators in other countries, Patel says.


Congress must still review and vote on the new user fee agreement before it takes effect on October 1, 2017, but once approved it would last until 2022. Patel hopes to begin staffing up the new digital health unit so that it can be ready by the time that next fiscal year deadline rolls around.


When asked why prospective hires might leave the perks and pay of the private sector to join a government agency, Patel pointed to his own example and the FDAs sense of mission. He added that recruits would have a huge influence in shaping the future of the industry as it rolls out new digital health products and services.


I spent 30 years in industry and Im here, Patel says. What keeps me coming back to this is that I do feel like I impact the lives of people by making choices that enable safe innovation, and I hope thats exciting for folks who might come here.


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Health Canada Investigating 2 Allegations of Babies Burned by Banana Boat Sunscreen

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BMW Recalling 45,000 7-Series Over Faulty Doors

IHS Global Insight

May 30, 2017

BMW has announced a recall of 45,484 units of the 7-series cars in the United States, according to a report by Automotive Newsciting documents filed with the U.S. National Highway Traffic Safety Administration (NHTSA). The recall covers vehicles equipped with the Comfort Access or Soft Close Automatic doors and affects model-year 2005-08 745i, 745Li, 750i, 750Li, 760i, 760Li and B7 Alpina vehicles. These vehicles doors are potentially faulty, creating a risk they either cannot be closed or unexpectedly open while the car is in motion. In these vehicles, the door can appear to be closed, although it has stopped in a position where the main detent is not fully engaged. Thus, an external influence [force] such as an irregular road surface, or an inadvertent interior contact by a vehicle occupant with the door, could result in an unexpected opening of the door while driving, said NHTSA. This could result in a crash or injury.


Significance: The recall is scheduled to begin on July 10. No accident or injuries in connection with the problem have been reported, according to NHTSA. The recall is related to the 2012 recall of 7,485 7-series cars of model year 2005 to 2007, which the automaker attributed to a software error that could cause doors to open unpredictably. All the cars from the 2012 recall are included in BMWs new callback. BMW has also recalled over 9,000 i3 REx plug-in hybrid electric vehicles in the United States.


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Golden Gourmet Recalls Frozen Waffle and Turkey Sausage Products Due to Possible Listeria Contamination

States News Service

May 30, 2017

Golden Gourmet, an Americus, Ga. establishment, is recalling approximately 5,248 pounds of frozen entree products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agricultures Food Safety and Inspection Service (FSIS) announced today.


The frozen waffles with turkey sausage patty items were produced and packaged on December 21, 2016, December 28, 2016, December 29, 2016 and December 30, 2016. The following products are subject to recall:


5,248 lbs. of 7.1-oz. trays with clear film in cardboard box packages containing Waffles, Turkey Sausage Patty with Sliced Apple Seasoned w/Brown Sugar and Cinnamon on the label, lot codes of 2016355, 2016363, 2016364 and 2016362, and Use By dates of 06/21/18, 06/28/18, 06/29/18 and 06/30/18.


The products subject to recall bear establishment number P-51269 inside the USDA mark of inspection. These items were shipped to institutions in Georgia, Iowa, Illinois, Ohio, South Carolina and Tennessee.


The problem was discovered on May 19, 2017 when Golden Gourmet received a letter of notification from its supplier, U.S. Foods, about products that had been recalled. Golden Gourmet notified FSIS on May 23, 2017 about the inclusion of recalled U.S. Foods product in Golden Gourmet products. There have been no confirmed reports of adverse reactions due to consumption of these products.


Consumption of food contaminated with L. monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.


Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.


FSIS and the company are concerned that some product may be frozen and in consumers freezers.


Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.


FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.


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