Z-1918-2015Class II

StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic...

Name: Z-1918-2015 StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic...
Creator: New Star Lasers, Inc.
Published: 2015-05-13
License: https://open.fda.gov/license/

New Star Lasers, Inc. / initiated 2015-05-13 / Terminated / root cause: software

FDA source

New Star Lasers, Inc. began a recall of StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation... on 2015-05-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1918-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-06-27
Terminated: 2016-10-28
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.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1918-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1918-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code GEX

K142286Class IINS3000 Holmium Laser SystemNew Star Lasers, Inc. / cleared 2014-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)