Z-2210-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- April 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Reason for Recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Code Information
GTIN: 00763000711344, Serial Numbers: RSC604641S, RSC604642S, RSC604643S, RSC604644S, RSC604647S, RSC604653S, RSC604654S, RSC604655S.