Events

Recall of Device Recall Compensator Slider Lambda 6x20 component

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
    67178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0799-2014
  • Event Initiated Date
    2013-12-20
  • Event Date Posted
    2014-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124877
  • 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 has recalled the compensator slider lamda 6x20 component utilized on standard pathology microscopes due to misalignment of the lambda plate.
  • Action
    Carl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.

Device

Device Recall Compensator Slider Lambda 6x20 component
  • Model / Serial
    part number 473704-0000-000
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
  • Product Description
    Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). || Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
  • 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