Reported Jan 25, 2017 · Terminated
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a…
Dicom Grid Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DICOM GRID INC · 4530 E Muirwood Dr · Phoenix, AZ · 85048-7639
Is this the product you have?
- Ambra PACS UDI+AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R
- Software Version NumberV3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images
- Amount recalled
- 209
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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