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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 Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recall Number Z-0568-2014
Classification Class II
Code Info 20006 20025 20142 20185 20216 20231 20015 20026 20151 20186 20217 20236 20016 20027 20153 20189 20225 20018 20031 20166 20198 20227 20019 20139 20184 20199 20228
Product Distributed Qty 27 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.