Company: GE Medical Systems.
Date of Enforcement Report 12/22/2010
Class ll:
PRODUCT
Signa Excite” 1.5 T Magnetic Resonance Systems. Recall # Z-0462-2011p>
REASON
Signa? MR Excite” 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip along the phase encode direction and incorrect annotation, which may result in incorrect localization of anatomy in oblique axial images with the pulse sequences
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by letter dated April 21, 2009. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1,464
DISTRIBUTION
Nationwide and internationally
