Recall Z-2215-2024— Thoratec Switzerland GMBH
Class II · Ongoing
Class II FDA medical device recall by Thoratec Switzerland GMBH, initiated 2024-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 2nd 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. Reason: 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..
- Recalling firm
- Thoratec Switzerland GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-22
- Firm location
- Zurich, Switzerland
Product description
2nd 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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.