Z-3119-2011

Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and...

Name: Z-3119-2011 Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2011-07-20
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2011-07-20 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products Inc began a recall of 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... on 2011-07-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3119-2011
Status: Terminated
Initiated: 2011-07-20
Posted: 2011-09-01
Terminated: 2013-07-05
Recalling firm: Gentherm Medical, LLC
Product: 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.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 27, 2011, to all affected user/customers. The letter includes: description of device; the problem with the suspect manuals, and provides contact information for the customers to use to request new versions of the manuals. Upon receipt of the new manuals, the customers are asked to immediately collect and destroy/discard all of the old manuals at their facility and to replace them with the new versions. After the manuals have been discarded and replaced, the customers are asked to complete and return the attached "Recall Response Form" via fax to (513) 772-9119 or scan and email to [email protected] or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, OH 45241. For additional information the customers are provided with an e-mail address: [email protected] as well as a toll-free telephone number and fax number to reach the firm and obtain additional information as necessary. The contact numbers are: 1 (800) 989-7373, or (513) 772-8810, and/or fax # (513) 772-9119..
Quantity in commerce: 6561 units were distributed.
Distribution: Nationwide distribution: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: The WarmAir Model 135 device has the 510(k) #K101148, and the literature associated with device Serial Numbers: 994-1350001 through 104-1356894, is subject to recall/correction. Part Number: 86185 (100V WarmAir 135 device) 86186 (115V WarmAir 135 device) 86187 (230V/240V WarmAIr 135 device)

Product code DWJ

K101148Class IIWarm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. / cleared 2010-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)