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U.S. Department of Health and Human Services

Class 2 Device Recall Ziehm Vision R Mobile Carm

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 Class 2 Device Recall Ziehm Vision R Mobile Carmsee related information
Date Initiated by FirmApril 15, 2016
Create DateAugust 25, 2016
Recall Status1 Terminated 3 on July 18, 2019
Recall NumberZ-2642-2016
Recall Event ID 74013
510(K)NumberK061203 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductZiehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Code Information Serial # 10841.
Recalling Firm/
Manufacturer		 Ziehm Imaging Inc
6280 Hazeltine National Dr Ste 100
Orlando FL 32822-5114
For Additional Information ContactNational Service Team
866-949-4346
Manufacturer Reason
for Recall		Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
FDA Determined
Cause 2		Device Design
ActionZiehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.
Quantity in Commerce1 device
DistributionUS Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWB
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