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.
What this means for you
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
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