Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conduc…

Recall date

July 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2291-2019

FDA classification

Class III

Brand / firm

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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