New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy
New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a malfunction could lead to unintended energy delivery during surgery, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
New Star Lasers, Inc. is recalling 52 units of the StoneLight 30 Laser System (NS3000). The device is used in surgical procedures for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue in specialties including Urology, Urinary Lithotripsy, and General Surgery.
The recall was initiated after internal testing revealed that when changing settings, a new setting might not be accepted. This malfunction could result in a discrepancy between the energy actually delivered and the value displayed on the Graphical User Interface, potentially delivering higher or lower energy than intended.
The affected units were distributed worldwide, including in the United States (specifically CA, IL, AZ, FL, OH, MA, MI, and AL) and the Netherlands. Healthcare providers should stop using the affected devices and contact New Star Lasers for instructions on the recall.
The recalled product
- 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…
- Manufacturer
- New Star Lasers, Inc.
- Category
- Medical Device — Surgical Laser
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Related recalls
Same manufacturer · New Star Lasers, Inc.
See all →- ModerateNew Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
FDA (Devices) · 2016-10-12
- ModerateNew Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues
FDA (Devices) · 2016-10-12
- ModerateNew Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
FDA (Devices) · 2016-10-12
Similar recalls
- ModerateNew Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
FDA (Devices) · 2016-10-12
- ModerateNew Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues
FDA (Devices) · 2016-10-12
- ModerateNew Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
FDA (Devices) · 2016-10-12
- HighBoston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation
FDA (Devices) · 2019-05-29
- HighRa Medical Systems Recalls DABRA Laser Due to Software Issue
FDA (Devices) · 2020-07-15
- HighAbbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
FDA (Devices) · 2013-10-30