Recall Z-0589-2016— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0589-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-13

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2015-11-13, terminated 2017-04-07. It names one FDA 510(k) clearance: K031544. Product: 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.. Reason: 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..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2015-11-13
Terminated: 2017-04-07
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031544 — HEATER COOLER UNIT, MODEL HCU 30Jostra AB·cleared 2003-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.