FDA Device recall Z-1817-2012
TX1 Tissue Removal System Console
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of TX1 Tissue Removal System Console by American Optisurgical, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1817-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-22 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Optisurgical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1817-2012%22
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