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U.S. Department of Health and Human Services

Class 2 Device Recall RITA Main Cable

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 Class 2 Device Recall RITA Main Cablesee related information
Date Initiated by FirmJune 11, 2013
Date PostedJuly 10, 2013
Recall Status1 Terminated 3 on June 12, 2015
Recall NumberZ-1675-2013
Recall Event ID 65439
510(K)NumberK040989 
Product Classification Electrosurgical, cutting & coagulation &accessories - Product Code GEI
ProductAngioDynamics 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.
Code Information Catalog #700-101892, Lot number: 30.12
Recalling Firm/
Manufacturer
Angiodynamics, INC
1 Horizon Way
Manchester GA 31816-1749
For Additional Information ContactMark Frost
518-795-1981
Manufacturer Reason
for Recall
The RITA Main Cable product contains the incorrect Instructions for Use.
FDA Determined
Cause 2
Packaging process control
ActionConsignees 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.
Quantity in Commerce13 units
DistributionWorldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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