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.
FDA Recall Z-0934-2013 · Posted 2013-03-11
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2011-02-04
Date Terminated2014-01-27
Product Quantity48
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.
Firm Action
No consignee letter sent out. GE Healthcare's recall strategy was to replace the impacted cable on all affected Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ systems that were distributed. At this time, deployment of this recall is considered complete as of 9/6/2011.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K092004GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQGE Healthcare · 2009-08-25K061163INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPTGe Medical Systems, LLC · 2006-06-07K052412INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQGE Healthcare · 2005-09-16K050489INNOVA 2100Ge Medical Systems, LLC · 2005-03-11
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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