Reported Jan 13, 2016 · Terminated
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU)…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- Maquet HCU 30 Coolant Type R134A Filling weight 250
- g 120 V 50-60 Hz 1920 W Product UsageThe 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 704629/70103.4371HCU 30 Base Unit 200 - 240 V 704631/70103.4642HCU 30 Base Unit Canadian/US 705501/70103.4653Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001. - Amount recalled
- 100 Units (distributed in United States)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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