Reported Jun 27, 2012 · Terminated
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and…
American Optisurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Optisurgical Inc · 26902 Vista Ter · Lake Forest, CA · 92630-8123
Is this the product you have?
- TX1 Tissue Removal System Console
- ModelTX1 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
- Lot codes and dates
- Product Codes
LFLGEISerial #: 554000015540000255400003
- Part Order No554-0034-000 510(K) Mp.: K101561
- Product Codes
- Amount recalled
- 5units
Where it was sold
- Nationwide
- MN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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