Bios THERMI250 Radiofrequency System Recalled for Unintended Energy Emission
Bios S.r.l. is recalling 167 THERMI250 Radiofrequency Systems because they may continue to emit RF energy after the PAUSE button is pressed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (unintended RF energy emission) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Bios S.r.l. is recalling 167 units of the THERMI250 Radiofrequency System. The device is intended to provide heating to elevate tissue temperature for selected medical conditions.
The recall was initiated because, in some systems, the unit continues to emit radiofrequency (RF) energy after the PAUSE button is pressed. This malfunction could result in unintended heating of tissue.
The affected units were distributed in the United States (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) and internationally in Brazil, Canada, Israel, Japan, and Thailand. Users should stop using the device and contact the manufacturer for instructions.
The recalled product
- Product
- THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
- Manufacturer
- Bios S.r.l.
- Affected units
- 167
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial No. TS250-16G-088-1
- TS250-16G-089-1
- TS250-16G-090-1
- TS250-16G-094-1
- TS250-16G-097-1
- TS250-16G-098-1
- TS250-16G-106-1
- TS250-16G-109-2
- TS250-16I-116-1
- TS250-16I-120-1
- TS250-16I-121-1
- TS250-16I-122-1
- TS250-16I-123-1
- TS250-16I-124-1
- TS250-16I-127-1
- TS250-16I-128-1
- TS250-16I-129-1
- TS250-16I-130-1
- TS250-16I-134-1
- TS250-16I-135-1
Distribution
Related recalls
Other medical device recalls
- HighHeraeus Medical Recalls PALACOS R+G pro Bone Cement Due to Leakage Risk
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- LowFDA Recalls MICRO-TEMP LT Heat Therapy Systems Due to Tissue Damage Risk
FDA (Devices) · 2019-08-28
- HighBiosense Webster Recalls SMARTABLATE RF System Generator Units
FDA (Devices) · 2017-12-13
- ModerateTrumpf Medical Systems Recalls Surgical Camera Systems Due to Emission Issues
FDA (Devices) · 2018-03-07
- HighMRI System May Resume Scanning Above Safe Thermal Limits
FDA (Devices) · 2025-03-05
- HighStihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk
FDA (Devices) · 2019-01-30
- HighPhilips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors
FDA (Devices) · 2014-02-05