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U.S. Department of Health and Human Services

Class 2 Device Recall TX1 Tissue Removal System

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 Class 2 Device Recall TX1 Tissue Removal System see related information
Date Posted June 06, 2013
Recall Status1 Terminated on March 24, 2014
Recall Number Z-1516-2013
Recall Event ID 65113
510(K)Number K101561 
Product Classification Instrument, ultrasonic surgical - Product Code LFL
Product American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.



Code Information Serial#:
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Recalling Firm/
Manufacturer
American Optisurgical Inc
26902 Vista Ter
Lake Forest CA 92630-8123
For Additional Information Contact
949-580-1266
Manufacturer Reason
for Recall
The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
FDA Determined
Cause 2
Device Design
Action "Urgent Medical Device Recall" notifications letters were sent to customers on May 20, 2013 via USPS registered mail. Included in the Recall Notification Letter were the recommended actions and instructions for customers. Questions were referred to (949) 580-1266.
Quantity in Commerce 194 units
Distribution Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = AMERICAN OPTISURGICAL, INC.
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