Recall – American Optisurgical’s TX1 Tissue Removal Cl ll

Company: American Optisurgical.
Date of Enforcement Report: 6/12/2013
Class ll:

PRODUCT
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

REASON
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.

RECALLING FIRM/MANUFACTURER
American Optisurgical Inc , Lake Forest, CA on 3/30/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
194

DISTRIBUTION
Nationwide and Internationally

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.