Recall Z-1817-2012— American Optisurgical Inc

Name: FDA recall Z-1817-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-22

Class II · Terminated

Class II FDA medical device recall by American Optisurgical Inc, initiated 2012-02-22, terminated 2012-06-15. It names one FDA 510(k) clearance: K101561. Product: 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 aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.. 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..

Recalling firm: American Optisurgical Inc
Classification: Class II
Status: Terminated
Initiated: 2012-02-22
Terminated: 2012-06-15
Firm location: Lake Forest, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101561 — TX1 TISSUE REMOVAL SYSTEMAmerican Optisurgical, Inc.·cleared 2010-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.