Events

Recall of Device Recall Polarizer D Fixed w/Rotating Red 1 lambda plate

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
    65355
  • Event Risk Class
    Class 2
  • Event Number
    Z-1744-2013
  • Event Initiated Date
    2013-05-28
  • Event Date Posted
    2013-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118619
  • 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
    Light, microscope - Product Code IBJ
  • Reason
    Carl zeiss microscopy, llc is recalling the polarizer d component used in all upright zeiss microscopes (axio imager, axio scope.A1, axio lab.A1) due to misaligned full-wave (lambda) plate.
  • Action
    On May 28, 2013, Carl Zeiss Microscopy, LLC recalled a Polarizer Component due to Misaligned Full-Wave (Lambda) Plate. Carl Ziess Microscopy distributed notices to their customers via e-mail. Carl Zeiss Microscopy, LLC requests that all customers immediately discontinue the use of the component for any applications which rely on accurate color-change sequence results. Your service provider will contact you to schedule a visit in which a factory trained service technician will confirm the alignment of your Polarizer D component;s lambda plate. If it is defective, a new Polarizer D component will be installed. There will be no charge for this action. Should you have any questions related to this issue, please do not hesitate to the Carl Zeiss facility in New York by telephone 914-681-7815 or via email at ed.mancini@zeiss.com

Device

Device Recall Polarizer D Fixed w/Rotating Red 1 lambda plate
  • Model / Serial
    Model # 445226-0000-000
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.
  • Product Description
    Polarizer D Fixed w/Rotating Red 1 lambda plate. || Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
  • 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