Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 800

  • Model / Serial
    all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan
  • Product Description
    Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall (FDA Z-1485-04).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pulmonetic Systems, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Source
    USFDA