Device product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Z-1261-2022
Product summary
- Event
- Event 90178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 96 systems
- Official record key
device-enforcement:Z-1261-2022
Official wording
Reason: Due to incorrect size and configuration labeling of the detachable coil system.
Code information: Product Number: QC-4-12-HELIX UDI-DI (GTIN) Code: 00847536029590 Lot Number: B240079 Product Number: QC-10-30-3D UDI-DI (GTIN) Code: 00847536030138 Lot Number: B240084
Distribution pattern: International distribution in the countries of China and Republic of Korea.
Derived failure modes
-
Unknown
Due to incorrect size and configuration labeling of the detachable coil system.