Devices

Device Recall PASCAL and PASCAL Streamline

  • Modèle / numéro de série
    PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
  • Description du dispositif
    PASCAL and PASCAL Streamline (532 nm.577 nm); || Treats the patient's eye.
  • Manufacturer
    Topcon Medical Laser Systems, Inc
  • 1 Event

Fabricant

Topcon Medical Laser Systems, Inc
  • Adresse du fabricant
    Topcon Medical Laser Systems, Inc, 3130 Coronado Dr, Santa Clara CA 95054-3205
  • Société-mère du fabricant (2017)
    Topcon Corporation
  • Source
    USFDA