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HEATER COOLER UNIT HCU 40 ( 2015-07-02)
- Starting date:
- July 2, 2015
- Posting date:
- July 21, 2015
- 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-54306
Affected Products
A.HEATER COOLER UNIT HCU 40
Reason
Maquet Cardiopulmonary recently detected a leak in the water circuit of an HCU 40 during the final quality inspection. The investigation revealed that the leakage was caused by a damaged sealant in the water circuit. The damage occurred during device assembly and it cannot be ruled out with absolute certainty that HCU 40s in the field equipped with the same type of sealant could exhibit this failure as well. The HCU 40 with the serial number 90440265 could potentially exhibit a leak in the water circuit. In case of water leakage a short circuit of an electrical component and device shut down are the potential consequences.
Affected products
A.HEATER COOLER UNIT HCU 40
Lot or serial number
90440265
Model or catalog number
70105.4054 (200-240V)
Companies
- Manufacturer
-
Maquet Cardiopulmonary Ag
Kehler Str. 31
Rastatt