Events

Recall of Device Recall Metrotom 800

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Metrology 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
    78885
  • Event Risk Class
    Class 2
  • Event Number
    Z-0379-2018
  • Event Initiated Date
    2017-11-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160805
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Reason
    Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
  • Action
    Zeiss sent an Safety Notice Letter dated September 28, 2017, to the customers advising them of the recall. The affected device was identified as well as the issue involved. Customers are to complete and return the confirmation- waiver form. During the next scheduled service event, a ZEISS field service technician will update the Metrotom operating system. The corrections are to be made free of charge, and will be completed by March 2018. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (763) 203-4267.

Device

Device Recall Metrotom 800
  • Model / Serial
    Serial Numbers:  152806 157499 157683 181193 181364 182887 186654 186767 186797 192099 192182 192351 197342
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
  • Product Description
    Metrotom 800 (130kV CT scanner) || Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
  • Manufacturer
    Carl Zeiss Metrology Inc

Manufacturer

Carl Zeiss Metrology Inc
  • Manufacturer Address
    Carl Zeiss Metrology Inc, 6250 Sycamore Ln N, Maple Grove MN 55369-6310
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA