Recall Z-0255-2016— GE Healthcare

Name: FDA recall Z-0255-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-31

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-08-31, terminated 2018-09-07. It names one FDA 510(k) clearance: K013636. Product: GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.. Reason: 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..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Terminated: 2018-09-07
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K013636 — SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYGE Medical Systems·cleared 2002-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.