American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
FDA Recall Z-1516-2013 · Posted 2013-06-06
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Recalling FirmAmerican Optisurgical Inc
Recall StatusTerminated
Product CodeLFL
Date Initiated2013-03-30
Date Terminated2014-03-24
Product Quantity194 units
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
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
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.
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