Heater-Cooler Unit HCU 40 (2020-08-17)
- Starting date:
- August 17, 2020
- Posting date:
- September 4, 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-73857
Last updated:
2020-09-04
Affected Products
Heater-Cooler Unit HCU 40
Reason
Maquet Cardiopulmonary GmbH has received complaints in relation to leaking vacuum valves of the HCU 40. Based on engineering testing, it is possible that after performing the emptying mode, the vacuum valve does not fully close. When the HCU 40 is then operated again, water can leak.
Affected products
Heater-Cooler Unit HCU 40
Lot or serial number
All units below serial number 90442012.
Model or catalog number
- 70104.4054 (200-240V)
- 70105.4917 (110-120V)
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY