American Optisurgical Recalls TX1 Tissue Removal System Consoles
American Optisurgical Inc is recalling five TX1 Tissue Removal System Consoles due to an incorrect pressure relief valve and inaccurate technical specifications.
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 FDA classified this as a Class II recall involving a risk-of-harm product where the source text describes a 'remote chance' of risk to health, and no specific injuries or illnesses are reported.
Plain-English summary
American Optisurgical Inc is recalling five units of the TX1 Tissue Removal System Console. The TX1 system is an ultrasonic aspirator used in surgical procedures to emulsify and remove soft tissue. The specific units affected are identified by serial numbers 55400001, 55400002, and 55400003, with a part order number of 554-0034-000.
The recall was initiated for two reasons. First, an incorrect pressure relief valve was installed inside the console, which the manufacturer states leads to a remote chance of a risk to health. Second, the technical specifications document contains an incorrect Operating Pressure value under the Irrigation section.
The affected units were distributed nationwide, specifically to Minnesota. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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 confi
- Manufacturer
- American Optisurgical Inc
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Codes: LFL
- GEI
- Serial #: 55400001
- 55400002
- 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
Distribution
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