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.
FDA Recall Z-1045-2017 · Posted 2017-01-18
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Recalling FirmDICOM GRID INC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-12-16
Date Terminated2017-04-07
Product Quantity209
Reason for Recall
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.
Firm Action
On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action.
Root Cause
Software change control
Distribution Pattern
U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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