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Terminated

GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

FDA Recall Z-0691-2008 · Posted 2008-01-31

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMQB
Date Initiated2007-11-15
Date Terminated2016-01-29
Product Quantity320

Reason for Recall

Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the

Firm Action

Customers were contacted by means of an Urgent Medical Device Correction Letter on November 9, 2007. The letter described the product and the safety issue. The letter also made short term recommendations and described a long term solution, which is pending as an expected hardware and/or software modification that will be made at no cost. Short Term Recommendation: Take extra care when working with motionless anatomy or devices where there is little evident motion to warn you of the frozen image occurrence. Always completely shut down and restart the system (not just reset) immediately after such an error occurs. Also, please immediately report this issue to your local GE Healthcare field service engineer.

Root Cause

Device Design

Distribution Pattern

Worldwide-USA including states of AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, SC, TN, TX, WA, WI, AK, AL, AZ, ,CT, DE, HI, ID, KS, KY, ME, MI, MN, MS, MT, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, UT, VA, WV, and Puerto Rico and countries of Hungary, Korea, Algeria, Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Finland, France, Georgia, Germany, Great Britain, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Turkey, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052412INNOVA 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 · 2005-08-25K042053INNOVA 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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