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Medi-Therm Hyper/Hypothermia System, MTA7900

FDA Device Recall #Z-2058-2017 — Class II — March 29, 2017

Recall Summary

Recall Number Z-2058-2017
Classification Class II — Moderate risk
Date Initiated March 29, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Medical Division of Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 119

Product Description

Medi-Therm Hyper/Hypothermia System, MTA7900

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.

Distribution Pattern

USA (nationwide) Distribution and Internationally to Colombia.

Lot / 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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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