American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in s
FDA device recall Z-1516-2013 · posted 2013-06-06 · Terminated
Recall details
- Recalling firm
- American Optisurgical Inc
- 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
- Action taken
- "Urgent Medical Device Recall" notifications letters were sent to customers on May 20, 2013 via USPS registered mail. Included in the Recall Notification Letter were the recommended actions and instructions for customers. Questions were referred to (949) 580-1266.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 194 units
- Distribution
- Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Marylan
- Date initiated
- 2013-03-30
- Date posted
- 2013-06-06
- Date terminated
- 2014-03-24
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TX1 TISSUE REMOVAL SYSTEM (K101561) | American Optisurgical, Inc. | 2010-08-27 |