FDA Device recall Z-1516-2013
American Optisurgical's TX1 Tissue Removal System Console
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of American Optisurgical's TX1 Tissue Removal System Console by American Optisurgical, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1516-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-30 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Optisurgical |
| Distribution | 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 |
Product
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Reason
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
Identifiers
| code_info | Serial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009…Serial#: 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 55400024 55400025 55400026 55400027 55400028 55400029 55400030 55400031 55400032 55400033 55400034 55400035 55400036 55400037 55400038 55400039 55400040 55400041 55400042 55400043 55400044 55400045 55400046 55400047 55400048 55400049 55400050 55400051 55400052 55400053 55400054 55400055 55400056 55400057 55400058 55400059 55400060 55400061 55400062 55400063 55400064 55400065 55400066 55400067 55400068 55400069 55400070 55400071 55400072 55400073 55400074 55400075 55400076 55400077 55400078 55400079 55400080 55400081 55400082 55400083 55400084 55400085 55400086 55400087 55400088 55400089 55400090 55400091 55400092 55400093 55400094 55400095 55400096 55400097 5 |
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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-1516-2013%22
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