Company: DICOM GRID INC
Date of Enforcement Report 1/25/2017
Class lI:
PRODUCT
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
Recall Number Z-1045-2017
REASON
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
RECALLING FIRM/MANUFACTURER
DICOM GRID INC, Phoenix, AZ on 12/16/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
209
DISTRIBUTION
Nationwide and Internationally
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