Jan

2017

Cl II Ambra PACS UDI

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Ambra PACS UDI

Amy Sellers

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