Gentherm Medical, LLC
Cincinnati, OH, US
Gentherm Medical, LLC appears in FDA device records in Cincinnati, OH. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Gentherm Medical, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cincinnati Sub-Zero Products LLC, a Gentherm Companyenforcement report, recall
- Cincinnati Sub-Zero Products, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Gentherm Medical, LLC between 1991 and 2013. The busiest year on record is 2012, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1995 | 2 |
| 2007 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS | DWJ | Substantially Equivalent | |
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | DWC | Substantially Equivalent | |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) | DWJ | Substantially Equivalent | |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | DWJ | Substantially Equivalent | |
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM | DWJ | Substantially Equivalent | |
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS | DWJ | Substantially Equivalent | |
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS | DWJ | Substantially Equivalent | |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR | BZT | Substantially Equivalent | |
| K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES | FLL | Substantially Equivalent | |
| K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) | DWJ | Substantially Equivalent | |
| K942599 | WARM AIR WARMING UNIT | DWJ | Substantially Equivalent | |
| K910327 | WARMAIR SYSTEM | DWJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1516825 | 1516825 | Gentherm Medical, LLC | 12011 MOSTELLER RD, Cincinnati, OH 45241 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2970-2026 | Blanketrol III, Model 233; Thermal regulating system. | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down, | Class II | Open, Classified | |
| Z-2969-2026 | Innercool Coolblue Console, Model STx; Thermal regulating system. | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. | Class II | Open, Classified | |
| Z-2968-2026 | Blanketrol II Model 222S; Thermal regulating system. | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. | Class II | Open, Classified | |
| Z-0496-2022 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. | Class II | Terminated | |
| Z-2092-2021 | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures | There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection. | Class II | Terminated | |
| Z-2291-2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer. | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage | Class III | Terminated | |
| Z-0419-2020 | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 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 | Class II | Terminated | |
| Z-0418-2020 | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 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 | Class II | Terminated | |
| Z-0417-2020 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | 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 | Class II | Terminated | |
| Z-2356-2019 | Norm-O-Temp model 111W | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. | Class II | Terminated | |
| Z-2355-2019 | Norm-O-Temp model 111Z | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. | Class II | Terminated | |
| Z-0825-2019 | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer. | 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. | Class II | Terminated | |
| Z-0063-2019 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer. | 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. | Class II | Terminated | |
| Z-0629-2018 | Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. | Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure. | Class II | Terminated | |
| Z-1825-2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Improperly rated fuses were used in the manufacture of the device. | Class II | Terminated | |
| Z-0654-2017 | The Hemotherm 400CE 115v, containing power board p/n 39945 | The device may not maintain water flow or temperature control. | Class II | Terminated | |
| Z-1129-2015 | Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient. | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. | Class II | Terminated | |
| Z-1679-2014 | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165. | The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but | Class II | Terminated | |
| Z-2209-2013 | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer. | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval. | Class II | Terminated | |
| Z-0443-2014 | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III. | During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer. | Class II | Terminated | |
| Z-1656-2012 | ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater, a circulating pump, fan, safety high limit, and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or, with the use of a 400 series probe, the fluid (external) temperature. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. | Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori | Terminated | ||
| Z-0970-2012 | Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The Hemotherm 48C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48C . | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution. | Terminated | ||
| Z-0969-2012 | Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The 48C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C. | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution. | Terminated | ||
| Z-0372-2012 | Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature. | Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error. | Terminated | ||
| Z-3119-2011 | Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket. | Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain