Thoratec Switzerland GMBH 2nd Generation CentriMag Primary Console, REF: 201-90401 recall — FDA Z-2215-2024
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the…