FDA Medical Device Recalls (openFDA)
New Star Lasers, Inc.: StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
- Recall number
- Z-1918-2015
- Recalling firm
- New Star Lasers, Inc.
- Product
- StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
- Status
- Terminated
- Initiated
- 2015-05-13
- Posted
- 2015-06-27
- Terminated
- 2016-10-28
- Reason
- 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.
- Root cause
- Software design (manufacturing process)
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Part Number: 0010-9400. Serial numbers: AMVM01, AMVM06, AMVM07, AMVG01, AMVP05, AMVP07, AMVP13, AMVS05, AMVK02, AMVS03, AMVS07, AMVE01, AMVS06, AMVP03, AMVS08. AMVS09, AMVS10, AMVS11, AMVS12, AMVM04, AMVM08, AMVM09, AMVM05, AMVS02, AMVK05, AMVP10, AMVS11, AMVP12, AMVP14, AMVP15, AMVP16, AMVP17, AMVP18. AMVS01, AMVK01, AMVK03, AMVK04, AMVK06, AMVK07, AMVK08, AMVK09, AMVK10, AMVM02, AMVM03, AMVM10, AMVP01, AMVP02, AMVP04, AMVP06, AMVP08, AMVP09, AMVS04.
- 510(k) numbers
- ["K142286"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000307100
- Firm city
- Roseville
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28