Medical DeviceNov 8, 2017
Bios S.r.l THERMI250 Radiofrequency System recall — FDA Z-0052-2018
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Class IIFDA: TerminatedBios S.r.l.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Bios S.r.l. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.