Device Recall Carestream Touch Prime and Carestream Touch Prime XE

  • Model / Serial
    Serial Numbers: US units: 106, 112, 114, 116, 1021, 1037, 1038, 1044, 1057, 1067, 1072, 1074, 1079, 1090; OUS units: 1005, 1006, 1009, 1011, 1015, 1017, 1018, 1020, 1031, 1041, 1042, 1043, 1045, 1081, 1086, 1089.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
  • Product Description
    Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System || Diagnostic ultrasound imaging or fluid flow analysis of the human body
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
  • Source
    USFDA