medical Class II Updated 2021-08-04

Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-

Recalled Product

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CA, FL, IL, KS, MI, MO, NC, NE, OH
Lot/Code Info: HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.
View official government recall

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