American Optisurgical Inc Recall: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue
American Optisurgical Inc Recall: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Optisurgical Inc; Product: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsif
| Recalling firm | American Optisurgical Inc |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide distribution: MN only. |
| Recall initiated | 20120222 |
| Recall number | Z-1817-2012 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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