| Date Initiated by Firm | May 25, 2016 |
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| Create Date | November 17, 2016 |
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| Recall Status1 |
Terminated 3 on August 28, 2019 |
| Recall Number | Z-0611-2017 |
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| Recall Event ID |
75497 |
| 510(K)Number | K092915 |
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| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. |
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| 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 |
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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. |
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FDA Determined
Cause 2 | Software design |
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| 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. |
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| Quantity in Commerce | 60 sites potentially have the affected versions |
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| Distribution | Distribution was made to medical facilities nationwide. Foreign distribution was also made. |
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| 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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