Device Recall Stryker SHAPE ARM, SINGLE

  • Modèle / numéro de série
    Serial numbers 111018DE001 through 140210DE020  Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
  • Description du dispositif
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Communications, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Société-mère du fabricant (2017)
  • Source
    USFDA