|
Class 2 Device Recall McKesson Horizon Medical Imaging |
|
Date Initiated by Firm |
September 04, 2013 |
Date Posted |
September 30, 2013 |
Recall Status1 |
Terminated 3 on February 06, 2017 |
Recall Number |
Z-2318-2013 |
Recall Event ID |
66301 |
510(K)Number |
K043146
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems. |
Code Information |
Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6. |
Recalling Firm/ Manufacturer |
Mckesson Information Solutions LLC 5995 Winward Plaza Information Technology Business Alpharetta GA 30005
|
For Additional Information Contact |
Paul Sumner 404-338-2376
|
Manufacturer Reason for Recall |
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
|
FDA Determined Cause 2 |
Software change control |
Action |
Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change. |
Quantity in Commerce |
329 units |
Distribution |
Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France. |
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 = MCKESSON MEDICAL IMAGING COMPANY
|
|
|
|