Device Recall Maquet Cardiopulmonary Heater Cooler Unit HCU30 Type 2

  • Model / Serial
    HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480  The affected power supply boards have serial numbers less than 107006001.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States Nationwide Distribution
  • Product Description
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W || Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
  • Source
    USFDA