American Optisurgical's TX1 Tissue Removal System Console — Class II medical device recall Z-1516-2013
Terminated recall by American Optisurgical Inc, reported 2013-06-12, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety prot
| Recall number | Z-1516-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Optisurgical Inc, Lake Forest, CA, United States |
| Recall initiated | 2013-03-30 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-03-24 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | PH, SG |
| Quantity | 194 units |
| Reason classes | packaging, device malfunction |
| Serial numbers | 5510124, 55400000, 55400001, 55400002, 55400003, 55400004, 55400005, 55400006, 55400007, 55400008, 55400009, 55400010, 55400011, 55400012, 55400013, 55400014, 55400015, 55400016, 55400017, 55400018, 55400019, 55400020, 55400021, 55400022, 55400023 and 181 more |
Product
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Reason for recall
The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1516-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.