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Cincinnati Sub-Zero Products LLC, a Gentherm Recalls
8 recalls on record · October 10, 2018 to November 27, 2019 · Medical Devices
Recalls by year
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 27, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of
Hazard: Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
November 27, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a com
Hazard: Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
November 27, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The
Hazard: Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
September 11, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Norm-O-Temp model 111W
Hazard: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
September 11, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Norm-O-Temp model 111Z
Hazard: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
August 28, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conduct
Hazard: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
February 20, 2019Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir
Hazard: Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
October 10, 2018Medical DevicesFDA
Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maint
Hazard: Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.