Lumenis Light Sheer Desire Diode Laser System Recalled for Software Error
Lumenis is recalling 117 Light Sheer Desire Diode Laser Systems because software parameters exceed manual settings, potentially causing burns.
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 is classified as FDA Class II and involves a risk of harm (burns and hypopigmentation) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Lumenis Limited is recalling 117 units of the Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. The recall is due to a software error where treatment preset parameters for the XC treatment handpiece do not match the Operator Manual and exceed recommended settings.
The Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type, which results in insufficient treatment effect. The FDA classifies this as a Class II recall because the defect may result in patient burns and hypopigmentation.
The affected devices were distributed worldwide, including in the United States (OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and the Russian Federation. Users should contact Lumenis Limited for instructions on how to resolve the software issue.
The recalled product
- Product
- Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
- Manufacturer
- Lumenis Limited
- Category
- Medical Device — Laser System
- Affected units
- 117
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)
- Lot numbers: XI0017
- XI0018
- XI0023
- XIP0043
- 182
- 184
- 185
- XIP0049
- 236
- 237
- 239
- 240
- 242
- 248
- 249
- 250
- 251
- 254
- 256
- 257
Distribution
Related recalls
Same manufacturer · Lumenis Limited
See all →- HighLumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions
FDA (Devices) · 2016-11-02
- SevereLumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections
FDA (Devices) · 2013-02-20
Same hazard · burn injury
See all →- SevereVQQQ Gas Patio Heaters Recalled for Fire and Burn Hazards
CPSC · 2026-10-22
- HighThomas Built Buses Recalls 2027 Saf-T-Liner C2 School Buses
NHTSA · 2026-10-21
- SevereDR Power Trimmer Mowers Recalled for Fire and Burn Hazards
CPSC · 2026-10-08
- SevereHyundai and Genesis Recall Vehicles Due to Front Seat Fire Risk
NHTSA · 2026-10-08
- SevereSnow Peak Recalls Propane Fireplace Inserts and Lava Rocks
CPSC · 2026-10-08
Similar recalls
- HighLumenis Vision One Laser System Recalled for Unintended Laser Exposure
FDA (Devices) · 2013-09-18
- HighLutronic DermaV Laser System Recalled for Potential Patient Burn Risk
FDA (Devices) · 2026-09-16
- HighRa Medical Systems Recalls Pharos Excimer Laser Due to Software Error
FDA (Devices) · 2020-04-08
- ModerateFDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues
FDA (Devices) · 2015-07-29
- HighFDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighLumenis M22 IPL Acne Filters Recalled for Superficial Burn Risk
FDA (Devices) · 2016-05-25