Device Recall Blease Sirius Anaesthesia Systems

  • Modèle / numéro de série
    Serial numbers: SIRI-000845, SIRI-000862, SIRI-000869, SIRI-000885, and SIRI-000898.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US in the states of LA and SD, and internationally by Spacelabs Healthcare, Ltd in the countries of China, Czech Republic, Hong Kong, India, Poland, Saudi Arabia, Singapore, and the United Kingdom.
  • Description du dispositif
    Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. || The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical Equipment Limited Beech House, Chiltern Court, Asheridge Road, Chesham, Bucks HP5 2PX, England...Spacelabs Healthcare Company Headquarters 5150 220th Ave. SE, Issaquah, WA 98029 PO Box 7018, Issaquah, WA 98027-7018".
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
  • Source
    USFDA