Enforcement Report - Week of June 27, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-1817-2012 |
| Classification | Class II |
| Code Info | Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561 |
| Product Distributed Qty | 5units |
| 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. |
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. |
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