Brand
Thoratec Switzerland GMBH
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Thoratec Switzerland GMBH and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-07-03FDA-DeviceClass II2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
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 console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
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