Company: GE Healthcare.
Date of Enforcement Report 11/18/2015
Class lI:
PRODUCT
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.
Recall Number Z-0257-2016
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
97
DISTRIBUTION
Nationwide and Internationally
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