Recall Z-1516-2013— American Optisurgical Inc
Class II · Terminated
Class II FDA medical device recall by American Optisurgical Inc, initiated 2013-03-30, terminated 2014-03-24. It names one FDA 510(k) clearance: K101561. 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.
- Recalling firm
- American Optisurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-30
- Terminated
- 2014-03-24
- Firm location
- Lake Forest, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.