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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Recall Number Z-0934-2013
Classification Class II
Code Info SERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7
Product Distributed Qty 48
Reason For Recall Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.

Event Detail

Event Id 64274
Product Type Devices
Status Completed
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-02-04
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
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