Events

Recall of Prism Laser 7642

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Stress Technologies, 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
    58804
  • Event Risk Class
    Class 2
  • Event Number
    Z-2600-2011
  • Event Initiated Date
    2011-04-27
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100331
  • 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
    Analytical measuring and detection laser product - Product Code REO
  • Reason
    It was discovered the prism 7642 was not certified at the time of delivery. the product lacks the required labeling and the product was sold and delivered without the submission of the initial product report. the product lacks user in formation.
  • Action
    American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030

Device

Prism Laser 7642
  • Model / Serial
    S/N 7642/2009
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Prism Laser 7642 || Laser System
  • Manufacturer
    American Stress Technologies, Inc.

Manufacturer

American Stress Technologies, Inc.
  • Manufacturer Address
    American Stress Technologies, Inc., 840 Watercrest Way, Cheswick PA 15024
  • Manufacturer Parent Company (2017)
    Nova Instruments Llc
  • Source
    USFDA