FDA Device recall Z-1519-2015

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options

FDA Device
Class II
terminated
Published 2015-05-06

On 2015-05-06 the FDA classified a Class II recall of Light Sheer Desire Diode Laser System with XC Handpiece Accessory options by Lumenis, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1519-2015
Classification	Class II
Status	terminated
Initiated	2015-03-25
Published	2015-05-06
Last updated	2026-09-13 11:53 UTC
Company	Lumenis
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	Lot numbers: XI0017, XI0018, XI0023, XIP0043, 182, 184, 185, XIP0049, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254,… 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

code_info

Lot numbers: XI0017, XI0018, XI0023, XIP0043, 182, 184, 185, XIP0049, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254,…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1519-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.