What are medical device recalls?

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

What are medical device recalls?

PostPosted by hopeful19 » Sun Jan 22, 2012 8:05 pm

What are Medical Device Recalls?
A recall is an action taken when a medical device violates FDA law. Recalls occur when a medical device could be a risk to health, is defective, or it is both a risk to health and defective.
A medical device recall does not necessarily mean that you must stop using the product or return it to the company. Sometimes it just needs to be checked, adjusted, or fixed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
There are 3 classes of recalls:
Class I -This is the most serious type of recall. It is used when there is a reasonable probability that the use of, or exposure to, the product being recalled will cause serious injury or death.
Class II -This type of recall is used when the recalled product may cause temporary or medically reversible injury or where the probability of serious injury is remote.
Class III -This is the least serious of all recall types. It is used when the recalled product is not likely to cause any injuries.
Typically it is the manufacturer, distributor or other responsible party that recalls devices on a voluntary basis once it is found that the device violates FDA law. The recall announcement typically details the actions to be taken by the users.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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