Z-1817-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2012
- Initiation Date
- February 22, 2012
- Termination Date
- June 15, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5units
Product 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.
Reason for Recall
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.
Distribution Pattern
Nationwide distribution: MN only.
Code Information
Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561