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.
Recall
- Recall Number
- Z-1817-2012
- Event Number
- 61253
- Firm
- American Optisurgical Inc
- FEI Number
- 1000135560
- Product Code
- LFL
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 22, 2012
- Posted
- August 8, 2013
- Terminated
- June 15, 2012
- Address
- 26902 Vista Ter, Lake Forest, CA, 92630-8123
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.
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.
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.
Nationwide distribution: MN only.
5units