Heater-Cooler Unit HCU 40 (2020-10-08)

Starting date:

October 8, 2020

Posting date:

October 23, 2020

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-74157

Last updated: 2020-10-22

• Reason
• Affected products

Affected Products

Heater-Cooler Unit HCU 40

Reason

Heat damage of the cable insulation at the crimp connections of the power cable and the internal electrical connection (L and N) cables between the main circuit breaker and line filter of the HCU 40 heater-cooler unit. Crimp connections of those cables did not always meet the requirements and acceptance criteria of the IPC/WHMA-A-620 standard. Inadequate crimp connections can result in higher temperatures leading to heat damage of the cable insulation.

Affected products