# FDA recall Z-2291-2019

> **Cincinnati Sub-Zero Products LLC, a Gentherm Company** · Class III · device recall initiated 2019-07-19.

## 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

- **Recall number:** Z-2291-2019
- **Recalling firm:** Cincinnati Sub-Zero Products LLC, a Gentherm Company
- **Classification:** Class III
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2291-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2291-2019. Source: US FDA. Licensed CC0.

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