Events

Recall of Device Recall INTRABEAM Shielding Material

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec, 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
    59362
  • Event Risk Class
    Class 2
  • Event Number
    Z-2989-2011
  • Event Initiated Date
    2011-07-01
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102395
  • 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
    Therapeutic X-ray System - Product Code JAD
  • Reason
    Carl zeiss meditec received a report that the intrabeam 20 x 20 cm sterile shield's packaging looked wet inside. investigation found the substance to be triethylene glycol,.
  • Action
    Carl Zeiss Meditec, Inc. sent an "Important Field Correction Action" letter dated July 13, 2011 to all affected customers. The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844.

Device

Device Recall INTRABEAM Shielding Material
  • Model / Serial
    Lot 110851; Catalog number 304534-6000-585.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.
  • Product Description
    INTRABEAM Shielding Material Flat 20 x 20 cm, || Sterile/FO || 0.05 mm Pb Equivalent (50keV) || Carl Zeiss Meditec AG || Indicated for radiation therapy treatments.
  • Manufacturer
    Carl Zeiss Meditec, Inc.

Manufacturer

Carl Zeiss Meditec, Inc.
  • Manufacturer Address
    Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin CA 94568-7562
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA