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Class 2 Device Recall Merge PACS |
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Date Initiated by Firm |
January 30, 2016 |
Create Date |
July 29, 2016 |
Recall Status1 |
Terminated 3 on April 08, 2019 |
Recall Number |
Z-2301-2016 |
Recall Event ID |
74648 |
510(K)Number |
K082144
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. |
Code Information |
Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3. |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
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For Additional Information Contact |
262-367-0700
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Manufacturer Reason for Recall |
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
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FDA Determined Cause 2 |
Software design |
Action |
The recalling firm issued Urgent: Medical Device Recall letters dated 1/27/2016 and 5/26/2016. The letter informed the customer of the affected product, the nature of the issue, the potential harm involved, and actions to be taken. The firm released a fix for the issue; and, customers were asked to complete and return the enclosed form by June 17, 2016. Questions can be directed to recall@merge.com. |
Quantity in Commerce |
109 sites have the affected versions |
Distribution |
Worldwide Distribution -- USA, New Zealand, and United Kingdom. |
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 and Original Applicant = AMICAS, INC.
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