Device product
AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
Z-1675-2013
Product summary
- Event
- Event 65439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-1675-2013
Official wording
Reason: The RITA Main Cable product contains the incorrect Instructions for Use.
Code information: Catalog #700-101892, Lot number: 30.12
Distribution pattern: Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Derived failure modes
-
Unknown
The RITA Main Cable product contains the incorrect Instructions for Use.