Data Foundry

Medical device recalls 2015

Light Sheer Desire Diode Laser System with XC Handpiece Accessory… — Class II medical device recall Z-1519-2015

Terminated recall by Lumenis Limited, reported 2015-05-06, distributed nationwide. Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, a

Recall numberZ-1519-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLumenis Limited, Yokneam, Israel
Recall initiated2015-03-25
Classified2015-04-24
Reported by FDA2015-05-06
Terminated2016-06-15
DistributedNationwide (US)
Countries outside the USAE, BE, CA, CH, CZ, DE, ES, FR, GB, IL, IN, IT, JP, KW, NZ, PT, SA, SI
Quantity117 units
Reason classessoftware
Lot numbers104, 182, 184, 185, 236, 237, 239, 240, 242, 248, 249, 250, 251, 254, 256, 257, 3048, 3052, 3065, 3074, XI0001, XI0005, XI0008, XI0012, XI0014, XI0015, XI0016, XI0017, XI0018, XI0021, XI0022, XI0023, XI0024, XI0026, XI0028, XI0029, XI0031, XI0034, XI0036, XI0037 and 85 more

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1519-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.