Events

Recall of Device Recall Coherent

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

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
    28434
  • Event Risk Class
    Class 2
  • Event Number
    Z-0357-04
  • Event Initiated Date
    2003-11-17
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31872
  • 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
    unknown device name - Product Code --
  • Reason
    Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.
  • Action
    On 11/7/03, all consignees were notified via Certified Mail and on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall Coherent
  • Model / Serial
    Serial Numbers/Model Numbers: TFAP0004P--TFAP00048
  • Distribution
    52 units were released for distribution to consignees in U.S. nationally.
  • Product Description
    Coherent brand Quattro Diode Laser Systems; || A Quattro FAP System; || Model Numbers/Serial Numbers: TFAP0004P--TFAP00048
  • Manufacturer
    Coherent Inc Laser Group

Manufacturer

Coherent Inc Laser Group
  • Manufacturer Address
    Coherent Inc Laser Group, 5100 Patrick Henry Dr, Santa Clara CA 95054-1112
  • Source
    USFDA