# FDA recall Z-0052-2018

> **Bios S.r.l.** · Class II · device recall initiated 2017-07-13.

## Product

THERMI250 Radiofrequency System.    Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

## Reason for recall

In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

## Distribution

AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV  Brazil, Canada, Israel, Japan, & Thailand.

## Key facts

- **Recall number:** Z-0052-2018
- **Recalling firm:** Bios S.r.l.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-13
- **Report date:** 2017-11-08
- **Termination date:** 2020-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vimodrone, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2018

## Citation

> AI Analytics. FDA recall Z-0052-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0052-2018. Source: US FDA. Licensed CC0.

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