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Terminated

GE Innova 2100IQ Versatile Cardiac and Vascular 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) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.

FDA Recall Z-2357-2008 · Posted 2008-09-21

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeMQB
Date Initiated2008-06-24
Date Terminated2011-12-17
Product Quantity275

Reason for Recall

GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab

Firm Action

The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.

Root Cause

Employee error

Distribution Pattern

USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM 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 · 2005-09-16

Official Source

View FDA Recall →

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

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