Z-1519-2015Class II

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options

Name: Z-1519-2015 Light Sheer Desire Diode Laser System with XC Handpiece Accessory options
Creator: Lumenis Limited
Published: 2015-03-25
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2015-03-25 / Terminated / root cause: software

FDA source

Lumenis Limited began a recall of Light Sheer Desire Diode Laser System with XC Handpiece Accessory options on 2015-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1519-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-25
Posted: 2015-04-24
Terminated: 2016-06-15
Recalling firm: Lumenis Ltd
Product: Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: Lumenis Limited sent an Urgent Safety Advisory Notice dated March 25, 2015, to all affected customers. Customers were instructed that Lumenis is eliminating the potential risk of patient harm through a software upgrade and Operator Manual replacement. The software upgrade must be completed by a Lumenis-certified engineer as soon as possible. In the Interim, customers can continue to use their LightSheer DESIRE system by following the recommendations in the operator manual to always perform a test patch prior to a full treatment. Customers with questions were instructed to contact the Aesthetic Business Unit Product Manager. For questions regarding this recall call 801-656-2690.
Quantity in commerce: 117 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1519-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-24

Product code GEX

K003614Class IILightsheer Pulsed Diode Array Laser SystemCoherent Star / cleared 2001-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)