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.
What this means for you
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
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