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.
FDA Recall Z-1675-2013 · Posted 2013-07-10
Recalling FirmAngiodynamics, INC
Recall StatusTerminated
Product CodeGEI
Date Initiated2013-06-11
Date Terminated2015-06-12
Product Quantity13 units
Reason for Recall
The RITA Main Cable product contains the incorrect Instructions for Use.
Firm Action
Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.