Recall Z-1817-2012 ยท LFL Instrument, Ultrasonic Surgical
American Optisurgical Inc
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiratio
| Date | Aug 8, 2013 (initiated Feb 22, 2012) |
| Status | Terminated |
| Reason | Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, American Optisurgical Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter via email on February 23, 2012. An updated "URGENT: MEDICAL DEVICE RECALL" recall letter dated March 1, 2012 was sent via email on March 1, 2012 to its customer. This updated recall letter described the product, problem and actions to be taken. The letter notified the two reasons for recall: " An incorrect pressure relief valve has been installed inside the console. Should the regulator that controls pressure delivered to the inflation cuff fail, the pressure relief valve would not open until a pressure of 1 |
| Quantity | 5units |
| Distribution | Nationwide distribution: MN only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101561 | TX1 TISSUE REMOVAL SYSTEM American Optisurgical, Inc., Aug 27, 2010 |