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American Optisurgical Inc recalls TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and
Recalled June 27, 2012 · FDA recall Z-1817-2012 · American Optisurgical
Hazard
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 Class II
Units
5units
Sold at
Nationwide distribution: MN only.
Description
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.
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.
Manufacturer(s)
American Optisurgical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →