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.
데이터 추가 비고
Interventional fluoroscopic x-ray system - Product Code OWB
원인
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.
조치
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
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.