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 and Original Applicant = CAMTRONICS MEDICAL SYSTEMS
|