Heater Cooler Unit, Model Hcu 30

• 2 recalls, same reason

  • Terminated Z-2140-2021 FDA Class II ·initiated 14 Jul 2021
  • Terminated Z-0348-2017 FDA Class II ·initiated 27 Sep 2016

  There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

• • Terminated Z-0589-2016 FDA Class II ·initiated 13 Nov 2015

  Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.

• • Terminated Z-0350-2007 FDA Unclassified (pre-2012) ·initiated 10 Nov 2006

  The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.

510(k) Number

K031544 ↗

FDA Product Code

DWC

Device Class

Class II

Regulation

21 CFR Part 870.4250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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