American Optisurgical Inc: Medical Device Recall in 2012 - (Recall #: Z-1817-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 22, 2012

Date Posted: June 27, 2012

Recall Number: Z-1817-2012

Event ID: 61253

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.

Status: Terminated

Product Quantity: 5units

Code Information:

Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561

Distribution Pattern:

Nationwide distribution: MN only.

Voluntary or Mandated:

Voluntary: Firm initiated