Device Recall iLab

  • Model / Serial
    Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 13 US consignees and 10 foreign consignees.
  • Product Description
    iLab Utrasound Imaging System, software controlled Imaging Catheter.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
  • Source
    USFDA