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U.S. Department of Health and Human Services

Class 2 Device Recall Ziehm Solo FD

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  Class 2 Device Recall Ziehm Solo FD see related information
Date Initiated by Firm February 23, 2017
Create Date May 17, 2017
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-1893-2017
Recall Event ID 77030
510(K)Number K161976  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Code Information S/N 52199, 52108
Recalling Firm/
Manufacturer		 Ziehm Imaging Inc
6280 Hazeltine National Dr Ste 100
Orlando FL 32822-5114
For Additional Information Contact
866-949-4346
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Labeling design
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
Quantity in Commerce US - 2 systems
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = ZIEHM IMAGING GMBH
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