Covidien Devon Light Glove

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions. Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ

11 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model: Item Numbers: 571711, 31140208, 31140216, 31140257, Affected: Lot numbers 508xxx or lower
  • Manufacturer
  • Modèle / numéro de série
    Model: 471711 31140208 31140216 and 31140257, Affected:
  • Manufacturer
  • Modèle / numéro de série
    Item Number: 31141784 Description: K-1960-S STANDARD MINI-KIT Item Number: 31140208 Description: 3611 FLEXBL LITE GLOVE 1EA/PKG Item Number: 31140216 Description: 3613 LITE GLV-FLEXIBLE 3EA/PKG Item Number: 31140257 Description: 3612 LITE GLV-FLEXIBLE 2EA/PKG Item Number: 571711 Description: NS-3600-B LITE GLOVE 1000/CASE
  • Description du dispositif
    Light Handle
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
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