Company: Philips Medical Systems, Inc.
Date of Enforcement Report 12/2/2015
Class lI:
PRODUCT
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Recall Number Z-0325-2016
REASON
When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 8/21/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
307
DISTRIBUTION
Worldwide
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