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: 12 units Lot/code info: UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800
07630002800761, 07630002813556
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.