Company: American Optisurgical.
Date of Enforcement Report: 6/12/2013
American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Recall Number Z-1516-2013
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 working.
American Optisurgical Inc , Lake Forest, CA on 3/30/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally