Events

Recall of Device Recall Surgical Laser Technologies, Inc. (SLT) SSRH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PhotoMedex, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64454
  • Event Risk Class
    Class 2
  • Event Number
    Z-0005-2014
  • Event Initiated Date
    2013-01-04
  • Event Date Posted
    2013-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116171
  • Notes / Alerts
    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.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
  • Action
    The firm initiated their recall of these products beginning on January 4, 2013 by sending notification letters to their consignees via electronic mail and/or facsimile. Customers were asked to return the affected product for a replacement.

Device

Device Recall Surgical Laser Technologies, Inc. (SLT) SSRH
  • Model / Serial
    Lot number 226201
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
  • Product Description
    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. || The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. || Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
  • Manufacturer
    PhotoMedex, Inc.

Manufacturer

PhotoMedex, Inc.
  • Manufacturer Address
    PhotoMedex, Inc., 147 Keystone Dr, Montgomeryville PA 18936-9638
  • Manufacturer Parent Company (2017)
    PhotoMedex Inc.
  • Source
    USFDA