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Terminated

Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , 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 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 for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.

FDA Recall Z-0392-2011 · Posted 2010-11-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2009-08-06
Date Terminated2012-05-17
Product Quantity43

Reason for Recall

GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. GE Healthcare has obse

Firm Action

GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions regarding this recall call (262) 548-2731.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN D=FEDERATION, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, ISLAMIC IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE, FINLAND , EGYPT, CHILE, CANADA, BULGARIA, BELGIUM BELARUS, AUSTRALIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023178INNOVA 4100Ge Medical Systems, Inc. · 2002-11-26K993037LCV+ VERSION 2Ge Medical Systems, Inc. · 2000-02-14

Official Source

View FDA Recall →

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

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