Events

Recall of INTRABEAM Balloon Applicator Set

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
    63596
  • Event Risk Class
    Class 2
  • Event Number
    Z-0405-2013
  • Event Initiated Date
    2012-10-25
  • Event Date Posted
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114296
  • 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
    System, therapeutic, x-ray - Product Code JAD
  • Reason
    A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
  • Action
    Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.

Device

INTRABEAM Balloon Applicator Set
  • Model / Serial
    Part number 304534-7500-001; lot number 540959.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL and MD
  • Product Description
    INTRABEAM Balloon Applicator Set; || 3.5 cm, || Carl Zeiss Meditec AG, Oberkochen, Germany || INTRABEAM System is intended 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