Events

Recall of DirectFRAP (Direct Flourescence Recovery After Photobleaching

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zeiss, Carl 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
    59285
  • Event Risk Class
    Class 2
  • Event Number
    Z-1129-2012
  • Event Initiated Date
    2011-04-28
  • Event Date Posted
    2012-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102130
  • 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
    Research laser - Product Code REK
  • Reason
    The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. the safety interlock is in place to prevent unintended exposure to class 3b laser radiation.
  • Action
    Carl Zeiss MicroImaging LLC, through trained personnel, first visited each user site, provided additional user instructions, re-labeled the components to provide adequate instruction and warning and further placed a label over the access to the locking screw which secures the component to the microscope. Carl Zeiss Inc. issued "IMPORTANT LASER SAFETY NOTICE: URGENT: FIELD CORRECTIVE ACTION" notices to each user by express courier in late April 2011, Carl Zeiss personnel will confirm that the relabeling has been performed and updated instructions for use have been provided. For questions, please contact the company. The firm will implement 2 actions. Service Representatives will visit each user site, provide additional user instructions, relabel the components to provide adequate instruction and warning, and add a label over the access to the locking screw which secures the component to the microscope. Secondly, when new replacement sensors are available, Carl Zeiss field service technicians will perform the component replacements. Modified components are anticipated to be available within 6 months and replacement completed by April 2012.

Device

DirectFRAP (Direct Flourescence Recovery After Photobleaching
  • Model / Serial
    All units manufactured are subject to correction.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide)
  • Product Description
    DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. || The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
  • Manufacturer
    Zeiss, Carl Inc

Manufacturer

Zeiss, Carl Inc
  • Manufacturer Address
    Zeiss, Carl Inc, 1 Zeiss Dr, Thornwood NY 10594-1939
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA