| Class 2 Device Recall Ambra PACS | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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