i feel the need to educate and clarify because Applied Medical's morons don't seem to understand the severity of this recall. A class 2 medical device is a pretty highly scrutinized device with greater regulatory controls than a class 1 (i.e. A pair of scissors). Basically this is going to take some time to work out. Hopefully our competitors can formulate a competitive response and this will be a lesson why not to do business with such a third world country medical device company like Applied:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm
"Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery"
In other words, BLOOD LOSS. Kind of a problem when your vessel sealer doesn't FUCKING seal you bargain basement, patient safety sacrificing scabs.
Yes, that can happen when you sell millions of units over the span of 20 years.
You guys were on the market for what, about 2 months in a handfull of accounts.
Good job fucktards.
Im sure youll be back at some point with your same lame ass message. Its easy to drop price, its hard to make an innovative product.
But you tools wouldnt know that would you.....
Voyant is now $250 a hand piece
"only?" Wow, considering thats probably 1/5th of the hand pieces you had on the market, I'd say that's a pretty good number. Also, I never knew the FDA was allowing companies to selectively choose what products/customers they can go to for a recall......that's a first.
Nonoptimal.... Now Thats funny.
Sounds like hiring Milton Waddams was a real boon!
Looks like you are new to Med Device."only?" Wow, considering thats probably 1/5th of the hand pieces you had on the market, I'd say that's a pretty good number. Also, I never knew the FDA was allowing companies to selectively choose what products/customers they can go to for a recall......that's a first.
Only ~100 units affected. We will replace them all. Don't make a small problem a big deal. Next....
Only ~100 units affected. We will replace them all. Don't make a small problem a big deal. Next....