Date Initiated by Firm |
July 02, 2012 |
Date Posted |
August 04, 2016 |
Recall Status1 |
Terminated 3 on June 26, 2017 |
Recall Number |
Z-2341-2016 |
Recall Event ID |
74577 |
510(K)Number |
K082421
|
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
Product |
Merge HEMO software. |
Code Information |
Software versions 8.10, 9.10, 9.20. |
Recalling Firm/ Manufacturer |
Merge Healthcare, Inc. 900 Walnut Ridge Dr Hartland WI 53029-8347
|
For Additional Information Contact |
262-367-0700
|
Manufacturer Reason for Recall |
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
|
FDA Determined Cause 2 |
Software design |
Action |
The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response. |
Quantity in Commerce |
37 |
Distribution |
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution. |
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 = DQK and Original Applicant = EMAGEON INC.
|