Date Initiated by Firm | October 26, 2015 |
Create Date | December 28, 2015 |
Recall Status1 |
Terminated 3 on July 22, 2016 |
Recall Number | Z-0555-2016 |
Recall Event ID |
72661 |
510(K)Number | K051649 |
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product | Merge Cardio with software version 10.1 LA. |
Code Information |
Merge Cardio with software version 10.1 LA. Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images. |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
|
For Additional Information Contact | n/a 262-367-0700 |
Manufacturer Reason for Recall | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. |
FDA Determined Cause 2 | Process control |
Action | Consignees were either contacted via phone 9/2015 or in person 7/31/2015.
The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release. |
Quantity in Commerce | 1 |
Distribution | Distributed in the states of IL, NC, and VT. |
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
|