StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, ex
FDA device recall Z-1918-2015 · posted 2015-06-27 · Terminated
Recall details
- Recalling firm
- New Star Lasers, Inc.
- Reason for recall
- During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display.
- Action taken
- Medical Device Correction letters were sent to all affected consignees by Federal Express on May 13, 2015. The letter identified the affected product as well as the issue and risk involved. The software will be upgraded to address the issue; and, the firm will contact customers to coordinate installation of the upgraded software. Customers may continue to use their system safely by taking the precautions provided in the letter. Customers are to complete the attached response form. Questions should be directed to Nina Davis at 916-677-1909.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 52 units
- Distribution
- Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.
- Date initiated
- 2015-05-13
- Date posted
- 2015-06-27
- Date terminated
- 2016-10-28
- Location
- Roseville, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NS3000 Holmium Laser System (K142286) | New Star Lasers, Inc. | 2014-10-31 |