FDA recall Z-2291-2019

Cincinnati Sub-Zero Products LLC, a Gentherm Company · Class III · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-07-19
Report date
2019-08-28
Termination date
2020-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2019