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Terminated

Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.

FDA Recall Z-1923-2010 · Posted 2010-06-29

Recalling FirmGe Healthcare, Llc
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-06-03
Date Terminated2015-09-28
Product Quantity69

Reason for Recall

GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.

Firm Action

Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050489INNOVA 2100Ge Medical Systems, LLC · 2005-03-11K042053INNOVA 4100, INNOVA 3100Ge Medical Systems, Inc. · 2004-08-26K033244DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTIONGe Medical Systems, Inc. · 2003-10-16K031637INNOVA 3100GE Medical Systems · 2003-08-22K023178INNOVA 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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