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U.S. Department of Health and Human Services

Class 2 Device Recall MediTherm Hyper/Hypothermia System, MTA7900

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 Class 2 Device Recall MediTherm Hyper/Hypothermia System, MTA7900see related information
Date Initiated by FirmMarch 29, 2017
Create DateMay 10, 2017
Recall Status1 Terminated 3 on September 18, 2017
Recall NumberZ-2058-2017
Recall Event ID 77014
510(K)NumberK912051 
Product Classification System, thermal regulating - Product Code DWJ
ProductMedi-Therm Hyper/Hypothermia System, MTA7900
Code Information Serial Numbers MTA7900A01004 MTA7900A01021 MTA7900A01029 MTA7900A01036 MTA7900A01037 MTA7900A80003 MTA7900A80004 MTA7900A80011 MTA7900A80016 MTA7900A80026 MTA7900A80027 MTA7900A80029 MTA7900A80030 MTA7900A80034 MTA7900A80035 MTA7900A80045 MTA7900A90006 MTA7900A90009 MTA7900A90023 MTA7900B90011 MTA7900B90019 MTA7900B90034 MTA7900B90036 MTA7900B90039 MTA7900C01016 MTA7900C01017 MTA7900D01015 MTA7900D01025 MTA7900D01029 MTA7900D80004 MTA7900D80018 MTA7900D80026 MTA7900D80030 MTA7900D80034 MTA7900D80035 MTA7900D80040 MTA7900E01018 MTA7900E01020 MTA7900E01023 MTA7900E01026 MTA7900E01028 MTA7900E01030 MTA7900E01034 MTA7900E01036 MTA7900E01041 MTA7900E80013 MTA7900E80047 MTA7900E80068 MTA7900E80077 MTA7900E90018 MTA7900E90028 MTA7900F01001 MTA7900F01007 MTA7900F01013 MTA7900F01015 MTA7900F01026 MTA7900F01035 MTA7900F01036 MTA7900F01038 MTA7900F01042 MTA7900F01049 MTA7900F01052 MTA7900F90019 MTA7900F90027 MTA7900F90030 MTA7900G01001 MTA7900G01002 MTA7900G01003 MTA7900G01006 MTA7900G01007 MTA7900G01008 MTA7900G01009 MTA7900G01012 MTA7900G01016 MTA7900G01017 MTA7900G01023 MTA7900G01025 MTA7900G90002 MTA7900G90003 MTA7900H80001 MTA7900H80004 MTA7900H80015 MTA7900H80030 MTA7900H90013 MTA7900I80003 MTA7900I80013 MTA7900I80035 MTA7900I90030 MTA7900J70001 MTA7900J70003 MTA7900J70006 MTA7900J70007 MTA7900J70008 MTA7900J70009 MTA7900J70010 MTA7900J70011 MTA7900J70013 MTA7900J70017 MTA7900J70018 MTA7900J70021 MTA7900J70030 MTA7900J70034 MTA7900J80044 MTA7900J80047 MTA7900J80049 MTA7900J80056 MTA7900J90030 MTA7900J90038 MTA7900K80009 MTA7900K90011 MTA7900K90012 MTA7900K90020 MTA7900K90028 MTA7900K90042 MTA7900K90062 MTA7900L70001 MTA7900L80006 MTA7900L80008 MTA7900L90013 
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information ContactCustomer Service
800-327-0770
Manufacturer Reason
for Recall		The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.
FDA Determined
Cause 2		Software design
ActionStryker sent an URGENT: MEDICAL DEVICE CORRECTION notification dated March 29, 2017, were sent to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions needed 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. In the interim, until the service can be performed, there are additional actions that users can and should take to ensure that the product operates safely. a. Attach the enclosed warning tags to the units listed in this notice. b. For units that do not have the water temperature displayed, advise staff not to switch to manual mode in order to display the water temperature. 3. Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email productfieldaction@stryker.com. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Medi-Therm unit. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. For further questions, please call (800) 327-0770.
Quantity in Commerce119
DistributionUSA (nationwide) Distribution and Internationally to Colombia.
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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