Date Initiated by Firm |
May 25, 2016 |
Create Date |
November 17, 2016 |
Recall Status1 |
Terminated 3 on August 28, 2019 |
Recall Number |
Z-0611-2017 |
Recall Event ID |
75497 |
510(K)Number |
K092915
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. |
Code Information |
Versions 3.0.1, 3.1, and 3.2 |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
|
For Additional Information Contact |
Merge Service and Support 877-741-5369
|
Manufacturer Reason for Recall |
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
|
FDA Determined Cause 2 |
Software design |
Action |
The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016. |
Quantity in Commerce |
60 sites potentially have the affected versions |
Distribution |
Distribution was made to medical facilities nationwide. Foreign distribution was also made. |
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 = CEDARA SOFTWARE CORP.
|