Health product recall

Heater Unit HU 35 (2019-08-06)

Starting date:
August 6, 2019
Posting date:
August 16, 2019
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-70737

Last updated: 2019-08-16

Affected Products

Heater Unit HU 35

Reason

The affected HU 35 heater unit(s) might have been delivered with an incorrect software version - not in correspondence with the set point temperature range described in the instructions for use. The affected units potentially have received the software version 1.01 Instead of the correct software version 1.02.In version 1.01 Of the HU 35 software, the set point water temperature can be set between 33°C and 39°C, while in the correct software version 1.02 For the set point temperature range is limited between 35°C and 39°C. Furthermore in software version 1.01 A high priority alarm (visual and acoustic alarm) is triggered if the water temperature falls to 32°C or below while in the new correct software version 1.02 A high priority alarm is already triggered if the water temperature drops to 34°C or below in order to avoid unintended hypothermia of a patient connected.

Affected products

Heater Unit HU 35

Lot or serial number

90034520
90034521
90034536
90034537
90034539

Model or catalog number

70107.2163

Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY