Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Cardiology Hemo

  • 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 Cardiology Hemosee related information
Date Initiated by FirmAugust 21, 2024
Date PostedOctober 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0127-2025
Recall Event ID 95284
510(K)NumberK050561 
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Horizon Cardiology Hemo. Version 12.2.
Code Information No UDI. Version 12.2
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
For Additional Information ContactMr. Jay Sloman
678-860-0782
Manufacturer Reason
for Recall		A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
FDA Determined
Cause 2		Use error
ActionChange Healthcare notified consignees on about 08/21/2024 via emailed letter. Consignees were instructed to pay careful attention to the hemoglobin unit of measurement displayed on the top of the "results" screen of the Hemo application, communicate the issue to all relevant team members to ensure vigilance in data entry, ensure that the hemoglobin values are entered in the correct unit of measurement (mmol/l or g/dl) as configured in the Management Console and displayed at the top of the results screen, contact Change Healthcare support to schedule the deployment of the software update that addresses this issue. Additionally, consignees were requested to complete and return the response form. With regard to potentially affected data, Change Healthcare recommended consignees verify f the UOM setting for hemoglobin is configured to what users would expect, if the UOM settings are different than expected, contact Change Healthcare support for assistance with identifying when the UOM setting was changed, and which procedures were affected, and examine affected procedures and implement necessary corrective actions to rectify the data and address patient care concerns.
Quantity in Commerce3 systems
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQK
-
-