Events

Recall of Device Recall Ziehm Imaging GmbH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ziehm Imaging 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
    66976
  • Event Risk Class
    Class 2
  • Event Number
    Z-0562-2014
  • Event Initiated Date
    2013-11-21
  • Event Date Posted
    2013-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124372
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Engineering change in 2006 resulted in a minor non-conformity of their devices. specifically the emergency switch was changed from a standard component to just an option on the devices.
  • Action
    Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation

Device

Device Recall Ziehm Imaging GmbH
  • Model / Serial
    5652 5704 5758 5772 5792 5840 5653 5714 5759 5773 5796 5844 5654 5715 5760 5774 5798 5846 5655 5716 5761 5775 5805 5847 5656 5717 5762 5776 5809 5854 5695 5718 5763 5777 5810 5855 5696 5720 5764 5779 5814 5860 5697 5721 5765 5780 5816 5861 5698 5722 5766 5781 5823 5862 5699 5723 5767 5782 5828 5863 5700 5749 5768 5783 5830 5864 5701 5750 5769 5784 5833 5865 5702 5751 5770 5785 5838 5866 5703 5755 5771 5787 5839
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
  • Product Description
    Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. || Mobile Fluoroscopic Imaging
  • Manufacturer
    Ziehm Imaging Inc

Manufacturer

Ziehm Imaging Inc
  • Manufacturer Address
    Ziehm Imaging Inc, 6280 Hazeltine National Dr, Suite 100, Orlando FL 32822-5114
  • Manufacturer Parent Company (2017)
    Aton 2 Gmbh
  • Source
    USFDA