Date Initiated by Firm |
April 04, 2016 |
Date Posted |
March 03, 2017 |
Recall Status1 |
Terminated 3 on July 26, 2019 |
Recall Number |
Z-1403-2017 |
Recall Event ID |
76590 |
510(K)Number |
K051649
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. |
Code Information |
Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0. |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
|
For Additional Information Contact |
Merge Service & Support 877-741-5369
|
Manufacturer Reason for Recall |
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
|
FDA Determined Cause 2 |
Software design |
Action |
Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016.
For further questions, please call (877) 741-5369. |
Quantity in Commerce |
110 sites potentially have the affected versions |
Distribution |
Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution. |
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.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = CAMTRONICS MEDICAL SYSTEMS
|