Events

Recall of Device Recall Carl Zeiss INTRABEAM PRS 500

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carl Zeiss Meditec AG.

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
    78082
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-2018
  • Event Initiated Date
    2017-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158631
  • 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
    The device had an incorrect printed calibration value on the calibration certificate.
  • Action
    Zeiss sent a Field Safety Corrective Action letter dated August 30. 2017, to all affected customers via FedEx. Recall letters were issued by the U.S. Agent on behalf of the /recalling firm on 8/30/2017 via FedEx. Customers were given the following instructions: 1. A member of the ZEISS service staff will contact you to coordinate the steps to be taken and to schedule the update of your system. Alternatively, you may update the system yourself by following the attached instructions. In case you update the system yourself, a ZEISS service staff member will still be visiting your site to confirm the updated calibration. 2. Please complete and return the attached response form to acknowledge receipt of this notification. If you have question regarding this field safety corrective action, you can contact your ZEISS customer service at 800-442-4020 or by email at iort.meditec.US@zeiss.com with any additional questions. You may also contact me at 925-557-4151 or viet.nguyen@zeiss.com

Device

Device Recall Carl Zeiss INTRABEAM PRS 500
  • Model / Serial
    Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
  • Product Description
    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. || The INTRABEAM System is indicated for radiation therapy treatments
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG
  • Manufacturer Address
    Carl Zeiss Meditec AG, Rudolf-Eber-Str. 11, Oberkochen Germany
  • Manufacturer Parent Company (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA