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Terminated

Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system

FDA Recall Z-0620-2010 · Posted 2010-01-13

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2009-12-22
Date Terminated2015-11-13
Product Quantity865

Reason for Recall

Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient

Firm Action

Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024200INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)Ge Medical Systems, Inc. · 2003-01-16K022322INNOVA AND INNOVA 2000 SGe Medical Systems, Inc. · 2002-10-08K993037LCV+ 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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