Device product

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

Z-2291-2019

July 19, 2019

Class III

Product summary

Firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Event: Event 83387
Status: Terminated
Classification: Class III
Quantity: 2079 units
Official record key: device-enforcement:Z-2291-2019

Official wording

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

Code information: Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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