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Terminated

GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

FDA Recall Z-1518-2008 · Posted 2008-09-30

Recalling FirmDatex - Ohmeda, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2006-08-17
Date Terminated2009-06-09
Product Quantity281

Reason for Recall

User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

Firm Action

GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

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 · 2005-08-25K050489INNOVA 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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