GE Healthcare recalls GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use…

Recall date

August 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0257-2016

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

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, GERMA…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.