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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 61253
Product Type Devices
Status Terminated
Recalling Firm American Optisurgical Inc
City Lake Forest
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide distribution: MN only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561 Class II 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. 5units Z-1817-2012
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