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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recall Number Z-0563-2014
Classification Class II
Code Info 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
Product Distributed Qty 58 devices
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.

Event Detail

Event Id 66976
Product Type Devices
Status Ongoing
Recalling Firm Ziehm Imaging Inc
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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