Events

Recall of Device Recall Laser Photolysis Probes/Handpieces

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by A.R.C. Laser Corp.

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
    26534
  • Event Risk Class
    Class 2
  • Event Number
    Z-0981-03
  • Event Initiated Date
    2003-06-06
  • Event Date Posted
    2003-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27848
  • 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
    Product may not have been properly sterilized.
  • Action
    The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.

Device

Device Recall Laser Photolysis Probes/Handpieces
  • Model / Serial
    Part Number: 1A55LM02 Catalog Number: LY11002
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IN, NY, PA, TX.
  • Product Description
    A.R.C. Laser Photolysis Probe/Handpiece
  • Manufacturer
    A.R.C. Laser Corp

Manufacturer

A.R.C. Laser Corp
  • Manufacturer Address
    A.R.C. Laser Corp, 2500 South Decker Lake Blvd., Suite 6, Salt Lake City UT 84119
  • Source
    USFDA