FDAFDA · Food and drugs·Recall number Z-1817-2012
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.
Published June 27, 2012 · Recall initiated: February 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Optisurgical Inc
- Distributor
- Nationwide distribution: MN only.
- Lot
- Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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