HeartWare Ventricular Assist System Controllers: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Italiano
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.
Il Gruppo di Coordinamento per le procedure di Mutuo Riconoscimento e
Decentrate per i medicinali ad uso Umano (CMDh), ha approvato con voto a
maggioranza le raccomandazioni per aggiornare il riassunto delle
caratteristiche del prodotto dei medicinali a base di ambroxol e
bromexina con le informazioni sul basso rischio di gravi reazioni
allergiche e gravi reazioni avverse cutanee (SCARs).
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.
Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.
Patients may be exposed to serious infections.
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