Z-2326-2020 Class II Ongoing
FDA device recall Z-2326-2020 was initiated by Canon Medical System, USA, INC. on March 3, 2020 and is designated Class II. Reason for recall: Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. The recall status is ongoing. Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- March 3, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason for Recall
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Distribution Pattern
US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
Code Information
Serial Numbers: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001