Devices

Device Recall HeaterCooler Device

Model / Serial
154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE
Product Classification
Cardiovascular Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Product Description
The Hemotherm 400CE 115v, containing power board p/n 39945
Manufacturer
Cincinnati Sub-Zero Products Inc
1 Event
- Recall of Device Recall HeaterCooler Device

Manufacturer

Cincinnati Sub-Zero Products Inc

Manufacturer Address
Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
Manufacturer Parent Company (2017)
Gentherm, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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