Device Recall Skytron Infinity Series surgical light

Fabricant

  • Adresse du fabricant
    Skytron, Div. The KMW Group, Inc, 5000 36th St Se, Grand Rapids MI 49512-2008
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada.
  • Description du dispositif
    Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL.
  • Manufacturer
  • Modèle / numéro de série
    Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada.
  • Description du dispositif
    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)
  • Manufacturer
  • Modèle / numéro de série
    Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers containing IN and 22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada.
  • Description du dispositif
    Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected).
  • Manufacturer