Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Reason for recall: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided Quantity: 4 shielding set Lot/code info: UDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669
07630002800761
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.