FDA recall on Voyant

Discussion in 'Applied Medical' started by Said, Sep 18, 2015 at 6:12 PM.

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  1. anonymous

    anonymous Guest

    I've almost used up my company 2G of data and I don't want them to charge me again would you mind just looking back 1 page?

    Cheapest fucking company ever!!!!!

    Voyant is recalled Class 2 !!!!!! Serious shit. I'm out!!! Mic dropped ..........
     

  2. anonymous

    anonymous Guest

    Class 2 Device Recall Voyant Open Fusion Device

    New Search [​IMG]
    Date Posted September 15, 2015
    Recall Status1 Open
    Recall Number Z-2769-2015
    Recall Event ID 71956
    Premarket Notification
    510(K) Number
    K143517
    Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
    Product Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
    Code Information Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
    Recalling Firm/
    Manufacturer
    Applied Medical Resources Corp
    22872 Avenida Empresa
    Rancho Santa Margarita, California 92688-2650
    For Additional Information Contact Karen Mitchell
    949-713-8622
    Manufacturer Reason
    for Recall
    Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
    FDA Determined
    Cause 2
    DESIGN: Device Design
    Action The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: -


     
  3. anonymous

    anonymous Guest

    That sucks!
     
  4. anonymous

    anonymous Guest

    I heard the announcement from my manager yesterday.
     
  5. anonymous

    anonymous Guest


    Still nothing from my manager. She's got her head up her ass.
     
  6. anonymous

    anonymous Guest

    Who's your manager?
     
  7. anonymous

    anonymous Guest

    You
     
  8. anonymous

    anonymous Guest

    My manager in the west also said the same. We are good to go.
     
  9. anonymous

    anonymous Guest

    Your Momma!!!! Is her wifi out? Wtf. Ring the bitch for me and communicate with the team.
     
  10. anonymous

    anonymous Guest

    1st case of the day and I see a hard copy of the Voyant recall in the invoice box Nice !!!
     
  11. anonymous

    anonymous Guest

    Ugh. I've been dreading that would start to happen. At least we got a week and a half before Covidien started dropping bombs.
     
  12. anonymous

    anonymous Guest

    Your misery is our pleasure.

    Go Covidien!
     
  13. anonymous

    anonymous Guest

    I'm going to call bullshit on this one. You didn't see anything.
     
  14. anonymous

    anonymous Guest

    Seriously? You dont think the competition isnt carpet bombing every account with the recall letter? Welcome to the big leagues junior. When you step on your own dick, the competition will make you pay. Ethicon, covidien, and olympus....

    But keep drinking the applied kool aid.
     
  15. anonymous

    anonymous Guest

    Yup it is back in the market.
     
  16. anonymous

    anonymous Guest

    there's an old saying: you get what you pay for. Garbage in, garbage out
     
  17. anonymous

    anonymous Guest

    Are products are the equivalent of Walmart house label products. Nothing original just cheaper. Cheaper not bc of all the vertical integration nonsense. There is no marketing and 0 insentive to sell more Socialist Selling.