Company: GE Healthcare.
Date of Enforcement Report 11/18/2015
Class lI:
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.
Recall Number Z-0258-2016
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/MANUFACTURER
GE Healthcare, Waukesha, WI. on 8/31/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
350
DISTRIBUTION
Nationwide and Internationally
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