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Class 2 Device Recall Cyberonics VNS Therapy System |
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Date Initiated by Firm |
October 17, 2006 |
Date Posted |
January 25, 2007 |
Recall Status1 |
Terminated 3 on October 02, 2009 |
Recall Number |
Z-0342-2007 |
Recall Event ID |
36672 |
PMA Number |
P970003 |
Product Classification |
VNS handheld PCs - Product Code LYJ
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Product |
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX. |
Code Information |
For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300; For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609 and 77-0000-7000; For Handheld v7.0: 10-0007-4300; For Handheld v7.1.3: 10-0007-8600. |
Recalling Firm/ Manufacturer |
Cyberonics, Inc 100 Cyberonics Blvd Houston TX 77058-2069
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Manufacturer Reason for Recall |
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
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FDA Determined Cause 2 |
Other |
Action |
Firm sent safety alert to physicians on 11/14/06. Safety Alert informs physicians of the problem and provides instructions on how to avoid an event and correct an event should it occur. |
Quantity in Commerce |
7,404 Handheld PCs pre-programmed with software. |
Distribution |
Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela. |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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