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Terminated

GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

FDA Recall Z-0137-2010 · Posted 2009-11-09

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeIYO
Date Initiated2009-04-16
Date Terminated2015-12-03
Product Quantity35

Reason for Recall

Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra

Firm Action

Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.

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 · 2005-08-25K042053INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc. · 2004-08-26K033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTIONGe Medical Systems, Inc. · 2003-10-16K023178INNOVA 4100Ge Medical Systems, Inc. · 2002-11-26

Official Source

View FDA Recall →

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

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