Device product
OptiCross Coronary Imaging Catheter, REF H749518080120
Z-1396-2024
Product summary
- Event
- Event 94162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 239 units
- Official record key
device-enforcement:Z-1396-2024
Official wording
Reason: Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Code information: UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
Distribution pattern: International distribution to the country of Japan.
Derived failure modes
-
Unknown
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.