Events

Recall of Device Recall Ziehm Solo FD

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
    77030
  • Event Risk Class
    Class 2
  • Event Number
    Z-1893-2017
  • Event Initiated Date
    2017-02-23
  • 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=154847
  • 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
    During ziehm imaging gmbh fda inspection, the label for the collimator and x-ray control panel was missing the manufacturer date as part of the identification for certified component.
  • Action
    Ziehm Imaging will bring defect into compliance: Customer Precautions: Therefore, as there is no identifiable risk to patients, users or third parties, the manufacturer Ziehm Imaging GmbH advises customers they may continue to operate the affected device until the labeling materials can be remediated. Please alert all staff members working with the device to this notification. Remedy: 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will affix the identification labels to the collimator and x-ray control panel. 3. You will replace the existing user manual with one that reflects the reference images of the labels with manufacturer date. If there are any questions or concerns regarding this product safety issue, please do not hesitate to contact our National Service Team for further information at Ziehm Imaging, Inc. Toll-Free: (866) 949-4346, Fax: (866) 839-7893 or E- Mail: customerservice@ziehm.com

Device

Device Recall Ziehm Solo FD
  • Model / Serial
    S/N 52199, 52108
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
  • Product Description
    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
  • Manufacturer
    Ziehm Imaging Inc

Manufacturer

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