GE HealthCare issued a Class I recall on its Nuclear Medicine 600/800 series due to a product design flaw that could injure patients. The company recommended that customers not use the equipment until a GE HealthCare service technician performs an inspection. Why did...
Product Liability
What are the different classes of FDA medical device recalls?
When the U.S. Food and Drug Administration issues a recall of a medical device, it will fall into one of three classes. The classes help to define how dangerous the issue with the device may be to patients. The FDA classes have simple Roman numerals. They are I, II...
What are the solutions to a medical device recall?
When a company has a recall of one of its medical devices, there are two general solutions it can take. The U.S. Food and Drug Administration will monitor the situation and ensure the company properly handles the medical device recall. The FDA provides guidance and...
How may I recognize and avoid defective medical products?
If you require a prescription medication or medical device and experience an adverse event, the product may have a defect. The ConsumerNotice.org website reports that before prescription products sell, they must pass at least three trials on humans. The process...
What are different kinds of medical device recalls?
Sometimes a medical company discovers that one of their medical devices has a defect that could cause harm to a patient and issues a recall. Medical device recalls are important to pay attention to because you may need to stop using a device as soon as possible to...
Some current news on medical device quality
Society relies on thousands of medical devices that obtain better outcomes for people around the world. Sometimes, though, these devices have problems that could negatively impact the treatment of patients. Medical professionals, medical facilities and manufacturers...
Certain sleep apnea devices may raise cancer, health risks
The maker of several ventilator products used by patients with sleep apnea has issued a recall for certain devices after receiving reports about associated health risks. The company, which manufactures certain mechanical ventilators that have a particular type of...
How does the FDA evaluate the risk of a defective medical device? [infographic]
When a company discovers that one of its medical devices is faulty, it should issue a recall to protect the public from any dangers the product poses. However, that does not necessarily mean everyone should immediately stop using the product. According to the U.S....
Who Is Liable for Food Allergen Injuries?
Consumers who are injured by severe allergic reactions to food may have the right to sue the company or restaurant that is to blame. The law imposes at least some obligations on food merchants to be mindful of customers' allergies and warn them of the possibility of a...
Why you shouldn’t ignore insulin pump recalls
Diabetic patients rely on an insulin pump rely on their device to deliver insulin correctly. When it does not do its job, manufacturers may recall the device but not always before it causes injury. According to the FDA, there is a database with medical device...
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