HEATER-COOLER UNIT HCU40 (2021-08-25)

Starting date:

August 25, 2021

Posting date:

September 10, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76405

Last updated:
2021-09-10

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  Reason
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  Affected products

Affected Products

HEATER-COOLER UNIT HCU40

Reason

Cleaning and/or descaling procedures for the internal water circuits can lead to crystalline deposits in the 3-way-valve promoting corrosion and malfunctions. In case of a malfunction of the 3-way valve, the valve does not close completely. In this case, a certain amount of warm water is not circulating in the main or patient circuit. Instead this warm water is guided back to the water tank leading to an increase of the water temperature and accelerated melting of the ice block. Consequently, the available time for the user to cool down the patient is reduced.

Affected products