Device Recall

  • Model / Serial
  • Distribution
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA

22687 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 110065 110077 110078 110081 110082 110084 110088 110090 110095 110096 110100 110102 110106 110109 110117 110121 110131 110137 110146 110147 110155 110158 110162 110163 110164 110169 110170 110174 110180 110189 110196 110197 110202 110205 110226 110227 110228 110231 110232 110248 110254 110259 110260 110264 110266 110268 110270 110275 110285 110286 110290 110298 110308 110314 110327 110328 110338 110347 110348 110349 110352 110355 110360 110363 110367 110368 110369 110373 110377 110381 110383 110385 110386 110387 110388 110392 110394 110395 110396 110397 110402 110408 110409 110410 110411 110413 110415 110419 110420 110424 110427 110434 110438 110441 110445 110446 110448 110451 110452 110453 110454 110455 110456 110457 110458 110459 110460 110461 110462 110463 110464 110465 110466 110467 110468 110469 110470 110471 110472 110473 110474 110475 110476 110477 110478 110479 110480 110481 110482 110483 110484 110485 110486 110487 110488 110489 110490 110491 110492 110493 110494 110495 110496 110497 110498 110499 110500 110501 110502 110503 110505 110507 110508 110504 110509
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.
  • Product Description
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). || The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.
  • Manufacturer
  • Model / Serial
    Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Product Description
    Customed O.B. Pack || convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
  • Model / Serial
    Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Product Description
    Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
  • Model / Serial
    Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Product Description
    Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
  • Model / Serial
    Product code 900-080, 37 lots: 109061259 109071681 109091967 109102245 109122679 110020427 110040863 110061419 110081951 111030731 111040866 111061577 111071877 111082180 111092575 111102818 111123295 111123409 111123475 112010012 112020300 112072820 112083049 112093839 112124910 113057408 113078229 113088827 113099264 131110145 131210670 140111082 140211626 140311911 140412449 140513057 140613558
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Product Description
    Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
22682 more