Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Ziehm Vision2 Mobile Carm

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Ziehm Vision2 Mobile Carm see related information
Date Initiated by Firm April 15, 2016
Create Date August 25, 2016
Recall Status1 Terminated 3 on July 18, 2019
Recall Number Z-2644-2016
Recall Event ID 74013
510(K)Number K073346  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Code Information Serial #'s: 91760 and 91770.
Recalling Firm/
Manufacturer		 Ziehm Imaging Inc
6280 Hazeltine National Dr Ste 100
Orlando FL 32822-5114
For Additional Information Contact National 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
Action Ziehm 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 Commerce 2 devices
Distribution US 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 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 = JAA and Original Applicant = ZIEHM IMAGING, INC.
-
-