American Optisurgical Recalls TX1 Tissue Removal System Consoles
American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical device losing power during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
American Optisurgical, Inc. is recalling 194 units of the TX1 Tissue Removal System Console. The console is a software unit indicated for use in surgical procedures. The recall was initiated due to a defect in the overheating protection voltage suppressor on the redundant safety protection circuit board.
The defect may cause the device to lose power and stop working. Additionally, the company is making a correction to add spacers between the valve and cassette to address a small irrigation leak that can occur after the priming cycle.
The affected units were distributed worldwide, including in the United States and in Singapore and the Philippines. Users should stop using the affected consoles and contact American Optisurgical for further instructions.
The recalled product
- Product
- American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
- Manufacturer
- American Optisurgical Inc
- Hazard
- Affected units
- 194
Distribution
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