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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 R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Recall Number Z-0567-2014
Classification Class II
Code Info 10016 10070 10135 10153 10235 10485 10026 10071 10092 10154 10260 10486 10028 10072 10093 10155 10265 10488 10030 10073 10094 10156 10266 10489 10031 10074 10109 10162 10396 10490 10038 10075 10111 10181 10431 10491 10042 10076 10117 10192 10434 10510 10045 10078 10118 10196 10435 10519 10046 10080 10119 10197 10436 10520 10048 10081 10121 10198 10443 10521 10049 10082 10122 10202 10457 10524 10053 10083 10123 10207 10458 10525 10054 10086 10124 10209 10459 10528 10056 10087 10125 10214 10460 10066 10088 10126 10215 10462 10067 10089 10127 10216 10472 10068 10090 10131 10223 10476 10069 10091 10134 10233 10484
Product Distributed Qty 103 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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