PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA device recall Z-1774-2013 · posted 2013-07-19 · Terminated
Recall details
- Recalling firm
- Topcon Medical Laser Systems, Inc
- Reason for recall
- When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
- Action taken
- Initial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 7 US, 33 foreign
- Distribution
- Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
- Date initiated
- 2012-03-27
- Date posted
- 2013-07-19
- Date terminated
- 2013-07-19
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PASCAL STREAMLINE PHOTOCOAGULATOR (K100019) | Optimedica Corporation | 2010-05-04 |