Reported Jun 12, 2013 · Terminated
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in…
American Optisurgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Optisurgical Inc · 26902 Vista Ter · Lake Forest, CA · 92630-8123
Is this the product you have?
- American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
- Lot codes and dates
- Serial#:
206 of 206 codes
55101245540000055400001554000025540000355400004554000055540000655400007554000085540000955400010554000115540001255400013554000145540001555400016554000175540001855400019554000205540002155400022554000235540002455400025554000265540002755400028554000295540003055400031554000325540003355400034554000355540003655400037554000385540003955400040554000415540004255400043554000445540004555400046554000475540004855400049554000505540005155400052554000535540005455400055554000565540005755400058
- Serial#:
- Amount recalled
- 194 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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