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U.S. Department of Health and Human Services

Class 2 Device Recall TX1 Tissue Removal System Console

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 Class 2 Recall
TX1 Tissue Removal System Console
see related information
Date Posted August 08, 2013
Recall Status1 Terminated on June 15, 2012
Recall Number Z-1817-2012
Recall Event ID 61253
Premarket Notification
510(K) Number
K101561 
Product Classification Instrument, Ultrasonic Surgical - Product Code LFL
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.
Code Information Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
Recalling Firm/
Manufacturer
American Optisurgical Inc
26902 Vista Ter
Lake Forest, California 92630-8123
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Quantity in Commerce 5units
Distribution Nationwide distribution: MN only.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LFL and Original Applicant = AMERICAN OPTISURGICAL, INC.
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