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U.S. Department of Health and Human Services

Class 2 Device Recall Ziehm Imaging GmbH

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 Class 2 Recall
Ziehm Imaging GmbH
see related information
Date Posted December 24, 2013
Recall Status1 Terminated on June 23, 2014
Recall Number Z-0563-2014
Recall Event ID 66976
Premarket Notification
510(K) Number
K092438 
Product Classification Interventional Fluoroscopic X-Ray System - Product Code OWB
Product Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Code Information 50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874
Recalling Firm/
Manufacturer
Ziehm Imaging Inc
6280 Hazeltine National Dr
Suite 100
Orlando, Florida 32822-5114
Manufacturer Reason
for Recall
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
FDA Determined
Cause 2
DESIGN: Device Design
Action Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation .
Quantity in Commerce 58 devices
Distribution USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = ZIEHM IMAGING, INC.
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