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GE Healthcare recalls GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for
Recalled November 18, 2015 · FDA recall Z-0258-2016 · GE Healthcare
Hazard
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans. · FDA Class II
Units
350
Sold at
Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
Description
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
Product
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →