Recall Z-0254-2016— GE Healthcare

Name: FDA recall Z-0254-2016
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: K132376. Product: GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.. 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

K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)·cleared 2013-11-15

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, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.

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.