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..

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
    30415
  • Event Risk Class
    Class 2
  • Event Number
    Z-0540-04
  • Event Initiated Date
    2004-01-19
  • Event Date Posted
    2004-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35827
  • 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 L22
  • Reason
    Software problem that may cause unintended emission of laser radiation.
  • Action
    On 1/19/04, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.

Device

Device Recall Coherent
  • Model / Serial
    The following Model---Serial Numbers (S/N) are affected:  P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 ¿ S/Ns 10019, 10019, 10020, 10043, and 10052.
  • Distribution
    10 US customers and 6 foreign customers in Canada, Germany, Japan received this product, with 1 wholesale dealer in Amersham Health, Durham, NC.
  • Product Description
    Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. || The following Model---Serial Numbers (S/N) are affected: || P/N 1024403---S/Ns 10026 Through 10088; || P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and || P. V. -4458 ¿ S/Ns 10019, 10019, 10020, 10043, and 10052.
  • Manufacturer
    Coherent, Inc.

Manufacturer

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