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Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

FDA Device Recall #Z-1519-2015 — Class II — March 25, 2015

Recall Summary

Recall Number Z-1519-2015
Classification Class II — Moderate risk
Date Initiated March 25, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Lumenis Limited
Location Yokneam
Product Type Devices
Quantity 117 units

Product Description

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

Reason for Recall

Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.

Distribution Pattern

Worldwide distribution. US nationwide (to 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 Russian Federation.

Lot / Code Information

Lot numbers: XI0017, XI0018, XI0023, XIP0043, 182, 184, 185, XIP0049, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254, 256, 257, XIP0038, XIP0131, XIP0125, 3048, 3052, 3065, 3074, XI0012, XIP0143, XIP0144, XI0001, XIP0072, XI0028, XIP0061, XI0028, XI0036, XIP0074, XIP0077, XIP0082, XIP0087, XIP0132, XIP0127, XIP0124, XIP0129, XI0008, XI0029, XI0037, XI0046, XIP0123, XIP0059, XIP0107, XIP0089, XIP0096, XIP0156, XI0005, XIP0114, XI0014, XI0022, XI0015, XI0021, XI0031, XI0034, XI0024, XI0026, XIP0047, XI0042, XI0039, XIP0044, XIP0025, XIP0035, XIP0041, XIP0030, XIP0051, XIP0057, XIP0113, XIP0067, XIP0053, XIP0083, XIP0058, XIP0055, XIP0060, XIP0066, XIP0163, XIP0071, XIP0063, XIP0120, XIP0088, XIP0081, XIP0064, XIP0050, XIP0101, XIP0062, XIP0095, XIP0121, XIP0094, XIP0108, XIP0105, XIP0122, XIP0119, XIP0104, XIP0097, 104, XIP0065, XIP0164, XIP0159, XIP0152, XIP0166, XI0016, XIP0045, XIP0052, XIP0158, XIP0092, XIP0111, XIP0086, XIP0086, XIP0086, XIP0112, XIP0130, XIP0157, XIP0093, XIP0151, XIP0149, XIP0167, XIP0168, XIP0162, XIP0171, XIP0138, XIP0118

Other Recalls from Lumenis Limited

Recall # Classification Product Date
Z-0301-2017 Class II FemTouch delivery system includes the FemTouch ... Sep 25, 2016
Z-0795-2013 Class I The Lumenis VersaCut Tissue Morcellator Pr... Jan 2, 2013

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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