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Terminated

GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.

FDA Recall Z-0947-2013 · Posted 2013-03-13

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2013-01-21
Date Terminated2014-01-16
Product Quantity297

Reason for Recall

A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

Firm Action

GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters dated January 18, 2013 and February 11, 2013 to all affected customers. The letters were addressed to Hospital Administrators / Risk Managers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The second letter dated February 11, 2013 was sent out to consignees which incorporated an additional model number (2270677-2) which was initially missed. Contact the firm 800-437-1171 for questions regarding these letters.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052157INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQGe Medical Systems, LLC · 2005-08-25K050489INNOVA 2100Ge Medical Systems, LLC · 2005-03-11K042053INNOVA 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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