Device Recall KODAK

  • Modèle / numéro de série
    Lot 2114596 (Exp. September 2014)
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
  • Description du dispositif
    KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. || Product Usage: || Dental intraoral radiography
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Carestream Health, Inc., 1669 Lake Avenue, Rochester NY 14652-3401
  • Société-mère du fabricant (2017)
  • Source
    USFDA

10 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Roll 027689-212, slits A/B/C, cartridges 12 - 19 ---  Lot Number: 027689212- A - 012 through -019 ---  Lot Number: 027689212- B - 012 through -019 ---  Lot Number: 027689212- C - 012 through -019
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of Alabama, Florida, Georgia, and Tennessee and the country of Australia.
  • Description du dispositif
    DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. || General purpose radiography.
  • Manufacturer
  • Modèle / numéro de série
    Catalog Numbers: 8551046, 8791345, 1333483, 8649253, 8864605, 1155118, 1295088, 1666700, 1845122, 1671841, 8245607, 8531675, 8966780; Service Code: 8087
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    DR 7500 with FF WS || These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
  • Modèle / numéro de série
    Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.
  • Description du dispositif
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
  • Manufacturer
  • Modèle / numéro de série
    Service Code 1534
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
  • Description du dispositif
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
  • Manufacturer
  • Modèle / numéro de série
    The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
  • Description du dispositif
    Kodak DirectView DR 7500 Diagnostic X-Ray System || Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
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