Events

Recall of Device Recall TX1 Tissue Removal System Console

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Optisurgical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61253
  • Event Risk Class
    Class 2
  • Event Number
    Z-1817-2012
  • Event Initiated Date
    2012-02-22
  • Event Date Posted
    2013-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107666
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, ultrasonic surgical - Product Code LFL
  • 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.
  • 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 10psi was achieved, which may present a health risk". "The Operator's Manual included with the system, Rev. 1, has a typographical error. Specifically, in Section E. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect". The updated recall included the above second reason for recall. The firm instructed the customer, for replacement of the pressure relief valve, and to return the revision 1 operator manual to the company's address using a pre-paid FedEx account. For questions call 949.580.1266 M-F, 7:00am to 5:00pm PST.

Device

Device Recall TX1 Tissue Removal System Console
  • Model / Serial
    Product Codes: LFL, GEI,  Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: MN only.
  • 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.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Manufacturer Address
    American Optisurgical Inc, 26902 Vista Ter, Lake Forest CA 92630-8123
  • Source
    USFDA