Retiro De Equipo (Recall) de Device Recall TX1 Tissue Removal System Console

Recall

61253

Class 2

Z-1817-2012

2012-02-22

2013-08-08

Terminated

United States

2012-06-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107666

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.