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U.S. Department of Health and Human Services

Class 2 Device Recall Ambra PACS

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  Class 2 Device Recall Ambra PACS see related information
Date Initiated by Firm December 16, 2016
Date Posted January 18, 2017
Recall Status1 Terminated 3 on April 07, 2017
Recall Number Z-1045-2017
Recall Event ID 76187
510(K)Number K152977  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information N/A
Recalling Firm/
Manufacturer		 DICOM GRID INC
4530 E Muirwood Dr
Ste. 113
Phoenix AZ 85048-7639
For Additional Information Contact
602-538-0061
Manufacturer 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.
FDA Determined
Cause 2		 Software change control
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.
Quantity in Commerce 209
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = DICOM GRID, INC.
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