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U.S. Department of Health and Human Services

Class 2 Device Recall NormOTemp Hyperthermia System

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 Class 2 Device Recall NormOTemp Hyperthermia Systemsee related information
Date Initiated by FirmJune 20, 2019
Create DateSeptember 04, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall NumberZ-2355-2019
Recall Event ID 83376
510(K)NumberK120081 
Product Classification System, thermal regulating - Product Code DWJ
ProductNorm-O-Temp model 111Z
Code Information Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154 
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products LLC, a Gentherm Company
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information ContactChristina Miracle
513-772-8810
Manufacturer Reason
for Recall		The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
FDA Determined
Cause 2		Labeling False and Misleading
Action1. Access updated manuals and ensure that obsolete manuals are removed from services. updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-5608 2. Inform the content of the notification to all users and if you have further distributed this product, please provide those account with a copy of this notice. 3. Please complete and return the enclosed response form as soon as receipt of this notification and to inform Gentherm Medical, LLC and return the form by e-mail to FA2019-005@gentherm.com or mail to : Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241. If you have any questions, call Gentherm Medical Technical Support at 1-888-437-5608.
Quantity in Commerce674
DistributionShip-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWJ
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