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Terminated

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

FDA Recall Z-2291-2019 · Posted None

Recalling FirmCincinnati Sub-Zero Products LLC, a Gentherm Company
Recall StatusTerminated
Product CodeILO
Date Initiated2019-07-19
Date Terminated2020-05-13
Product Quantity2079 units

Reason for Recall

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

Firm Action

Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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