Recall Z-1516-2013 ยท LFL Instrument, Ultrasonic Surgical
American Optisurgical Inc
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
| Date | Jun 6, 2013 (initiated Mar 30, 2013) |
| Status | Terminated |
| 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 wo |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101561 | TX1 TISSUE REMOVAL SYSTEM American Optisurgical, Inc., Aug 27, 2010 |