Reported Jul 8, 2015 · Terminated
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision,…
New Star Lasers, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: New Star Lasers, Inc. · 9085 Foothills Blvd · Roseville, CA · 95747-7130
Is this the product you have?
- 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 includingUrology, Urinary Lithotripsy, and General Surgery
- Lot codes and dates
- Part Number0010-9400
- Serial numbers
AMVM01AMVM06AMVM07AMVG01AMVP05AMVP07AMVP13AMVS05AMVK02AMVS03AMVS07AMVE01AMVS06AMVP03AMVS08. AMVS09AMVS10AMVS11AMVS12AMVM04AMVM08AMVM09AMVM05AMVS02AMVK05AMVP10AMVS11AMVP12AMVP14AMVP15AMVP16AMVP17AMVP18. AMVS01AMVK01AMVK03AMVK04AMVK06AMVK07AMVK08AMVK09AMVK10AMVM02AMVM03AMVM10AMVP01AMVP02AMVP04AMVP06AMVP08AMVP09AMVS04
- Amount recalled
- 52 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new New Star Lasers, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.