Events

Rappel de Device Recall Light Sheer Desire Diode Laser System with XC Handpiece Accessory options

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Lumenis Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70863
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1519-2015
  • Date de mise en oeuvre de l'événement
    2015-03-25
  • Date de publication de l'événement
    2015-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135279
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Powered laser surgical instrument - Product Code GEX
  • Cause
    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.
  • 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.

Device

Device Recall Light Sheer Desire Diode Laser System with XC Handpiece Accessory options
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
  • Manufacturer
    Lumenis Limited

Manufacturer

Lumenis Limited
  • Adresse du fabricant
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Société-mère du fabricant (2017)
    Laguna Holdco Ltd
  • Source
    USFDA