Health product recall

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

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

Heater-Cooler Unit HCU 40

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

70105.4917

Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY