Terminated

VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.

FDA Recall Z-1083-2013 · Posted 2013-04-10

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeIZL

Date Initiated2012-01-23

Date Terminated2014-02-04

Product Quantity1296

Reason for Recall

GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety.

Firm Action

GE Healthcare sent and "Urgent Medical Device Correction" letter dated January 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details and Product Correction. For questions contact your local GE Healthcare Service Represenative.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the states of: AR, CA, GA, IL, IN,IA,LA, MA, MN, MT, NY, OH, PA, TX, VA and the countries of BELGIUM, BURKINA FASO, BRAZIL, CHINA, CANADA, SWITZERLAND, CHILE, COLOMBIA, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, EGYPT, SPAIN, FRANCE, UNITED KINGDOM, CHANA, GUADELOUPE, GREECE, GUYANA, HONG KONG, CROATIA, HUNGARY, INDONESIA, ISRAEL, ITALY, KUWAIT, LEBANON LUXEMBURG, LIBYAN, MOROCCO, MARTINIQUE, MEXICO, NETHERLANDS, NORWAY, PANAMA, PERU, POLAND, PORTUGAL , REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SWEDEN, SINGAPORE, SLOVENIA, SLOVAKIA, SIERRA LEONE, THAILAND, TUNISIA, TURKEY, VENEZUELA, MACEDONIA, PALESTINE, SOUTH AFRICA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910902VMX MOBILE X-RAY SYSTEMGE Medical Systems · 1991-09-09

Official Source

View FDA Recall →

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