Z-2215-2024 Class II Ongoing
FDA device recall Z-2215-2024 was initiated by Thoratec Switzerland GMBH on May 22, 2024 and is designated Class II. 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 ma… The recall status is ongoing. Affected quantity: 3,425.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- May 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,425
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution included in the states of CA, PA, FL, IL, NY, AR, GA, WI, AZ, TN, TX, NC, MT, VA, MA, NJ, NE, WV, ME, OK, CO, OH, KC, WA, IN, CT, MI, OR, ID, MO, SC, KY, LA, NM, NV, VT, IA, MD and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRAN, IRAQ, ISRAEL, ITALY, KENYA, KOREA, KUWAIT, LITHUANIA, MACEDONIA MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM.