Homoth Medizinelektronik GmbH & Co.KG FSCA-LK-HO-15112019 - Luftkalorisator, Air Calorisator

As a part of our repair evaluation, Homoth Medizinelektronik has detected that, due to a possible production error, the medical devices li sted below {2012 to present year, blue LC displays) may not match with the relevant safety standard {DIN EN ISO 60601-1) in regards to fault safety. Potentially it is possible that an unfavorable defect of a component (short circuit of the circuit breaker to control the heating coil) may causes impermiss ible temperatures of the air flow and I or the handpiece. To our current knowledge the protective circuit designed for this case is not fully functional in all devices due to a faulty production. This event can Iead to impermissible temperatures (>+Sr C) with permanent activation of the heating coil.