• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS).

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS). see related information
Date Initiated by Firm December 23, 2013
Date Posted February 12, 2014
Recall Status1 Terminated 3 on April 25, 2017
Recall Number Z-0976-2014
Recall Event ID 67374
510(K)Number K043146  
Product Classification System, image processing, radiological - Product Code LLZ
Product Horizon Medical Imaging, Picture Archive Communication System (PACS).
Code Information HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.
Recalling Firm/
Mckesson Information Solutions LLC
5995 Winward Plaza
Information Technology Business
Alpharetta GA 30005
For Additional Information Contact Paul Sumner
Manufacturer Reason
for Recall
Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
FDA Determined
Cause 2
Software design
Action McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
Quantity in Commerce 618 units
Distribution U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
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