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Terminated

GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.

FDA Recall Z-1318-2013 · Posted 2013-05-14

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2011-12-20
Date Terminated2014-03-13
Product Quantity713

Reason for Recall

While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.

Firm Action

GE Healthcare did not send out customer letters. GE Healthcare completed the correction by replacing the faulty relay in all affected systems. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests recorded the repair of the affected units. Exceptions to completion of the service request were recorded as well. Records of field action completion will be retained per their processes and procedures. Should you have any questions or require additional information, please call (262) 548-2757.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061163INNOVA 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 · 2005-09-16K052157INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQGe Medical Systems, LLC · 2005-08-25K050489INNOVA 2100Ge Medical Systems, LLC · 2005-03-11K042053INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc. · 2004-08-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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