Tag: recalls
As medical companies join forces to advance medical technology, the rise in recalls and risks of hacking remain in our minds
Over the past few years, we have seen the digital world explode and incorporate in to everything we do. We have apps and gadgets for all sorts of things!
The medical industry has grasped this fairly new development to improve medical equipment and devices too. With ever advancing technology in treating patients, different medical companies are joining forces to introduce upgraded robotics, better visualisation, and improved bioelectronics.
However, the advancement of creations and collaborations have also seen a similar rise in medical device failures and the ever-present risk of hacking…
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Toyota recalls over 72,000 vehicles after safety concerns over sensitive resin bumpers
Japanese car brand Toyota are set to be recalling a total of 72,847 vehicles after concerns that overly sensitive resin bumpers may pose a safety risk to users. The recalls affect the newer 2016 and 2017 Tundra models.
The safety defect lies within the resin made step bumpers and resin reinforced brackets on the corners of the vehicle. Any impact made to the resin bumpers may not always reveal visible damage, but if stepped on, it could break way entirely or in part; risking injury to the user.
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Takata pleads guilty over momentous air bag scandal and have agreed to pay $1 billion in fines.
It seems the Takata airbag scandal is finally drawing to a close as the auto parts manufacturer, Takata Corp, has pleaded guilty to fraud in hiding the dangerous defect.
Based in Japan, the company found themselves in hot water as 16 deaths were connected to lethal Takata airbags that exploded inside car cabins. Whilst the majority of the fatalities were in the U.S., Takata airbags are used worldwide.
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Medical device maker Medtronic has recalled their adjustable pressure valves across the world
Medtronic has issued a worldwide recall over their unused StrataMR valve devices after numerous complaints have been raised.
In one of the complaints, one patient death is suspected to be related to the device. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent Field Safety Notice to distribute news of the recall in the U.K.
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Studies shows that companies wait too long to recall medical devices
How long is too long?
It seems that medical device companies do not prioritise the safety of their products above profits and reputation, as a study conducted by the University of Minnesota revealed that these companies tend to delay in recalling defective products.
When problems are not reported to relevant authorities – like the MHRA here in the UK – healthcare professionals and the public may be unaware of the complaints, and thus may continue to use defective products that may carry a significant risk of harm.
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Over 48,000 Mercedes-Benz SUVs recalled to fix dangerous airbag defect.
Several Mercedes-Benz models have been recalled due to a defect in their airbags. A failure in calibration has reportedly led to a software flaw that doesn’t always deploy airbags when needed.
Regulators investigating the matter noted:
“The front passenger seat Occupant Classification System (OCS) calibration may be incorrect, and as a result, the system can incorrectly classify the occupant as a child seat, deactivating the front passenger air bag.”
The Government has issued a medical drug alert alongside a voluntary recall of Viridal Duo Powder amidst concerns over defective cap seals compromising the sterility of the contents.
UCB Pharma Limited is voluntarily recalling their Viridial Duo Powder and Solvent for Injections after concerns that the cap seals are not strong enough. The cap seals are vulnerable to breaking and thus compromising the sterility of the contents.
Viridal Duo Powder and Solvents contain the active ingredient ‘Alprostadil’ and is used for adult males for diagnostic evaluation and treatment of erectile dysfunction. The prescription only injections for diagnostic evaluation purposes are carried out by a trained physician, who will monitor the dose need to produce an erectile response.
For the treatment of erectile dysfunction, this can be administered by a physician or by self-injection.
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Mylan EpiPen recall information
Anaphylaxis is a life-threatening reaction to certain allergens which can be found in foods, drugs, and even venom like in a wasp sting. Depending on the sufferer’s sensitivity to the allergens, anaphylactic shock can be caused by ingestion or even mere contact on skin.
Otherwise more commonly known as an allergic reaction, without the simple treatment, the consequences can be serious and even fatal. Anaphylactic shock can come on immediately, and in severe cases, symptoms can develop just as quickly. Some symptoms include swelling of the throat and face; wheezing; dizziness and fainting spells. If left untreated, individuals may have difficulty breathing to a point where they may stop doing so.
For these reasons, any life saving EpiPen recall is always a major concern.
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Class 3 recall: does the small crack in the blistering of tablet packaging impact their effectiveness?
The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended recalling instant pain relief tablets due to an issue with some batches.
Bayer plc is a pharmaceutical company who manufactured the pain relief tablets in question; Alka-Seltzer Original & Alka-Seltzer XS. Bayer noticed an issue with the blister foil and as a result, are voluntarily recalling them as a precautionary measure.
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Manufacturers of vital ventilation machines issued a Medical Device Alert after reports that the emergency devices stop working due to oxide build up.
Drager has issued a ‘risk of failure’ alert to all users after multiple reports were made complaining that ventilation devices had stopped working.
This is reportedly not the first time the company has received these complaints. Dräger has now issued a second Field Safety Notice for the Oxylog 3000 and Oxylog 3000 plus ventilators.
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Heart pump device production has been halted due to patient death
A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.
Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.
The device was initially thought to be commercially promising, but the problems identified are serious.
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General Motors company to pay $1 million for lack of communication with accountants
General Motors is set to pay $1 million in civil penalty fines for not notifying accountants of a proposed recall.
Back in Spring of 2012, the company were aware of a potential safety recall, but reportedly failed to let accountants know. This failure prevented accountants from assessing the financial impact the recall may have, including any potential losses. This information was allegedly kept from accountants for around 18 months, though it is unclear whether this was intentional or an expensive oversight.
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