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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Cardiology ECG Management

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 Class 2 Recall
Horizon Cardiology ECG Management
see related information
Date Posted January 13, 2011
Recall Status1 Terminated on August 17, 2012
Recall Number Z-0900-2011
Recall Event ID 57436
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
Code Information K061905; Versions 12, 12 SP1, 12 SP1 HF2, 12 SP1 HF4, 12.1, 12.1 HF1, 12.1 HF2
Recalling Firm/
Manufacturer
McKesson Provider Technologies - Medical Imaging Group
1639 State Rt 10 Ste 100
Parsippany, New Jersey 07054-4506
For Additional Information Contact Rick Gary
973-355-9900
Manufacturer Reason
for Recall
When importing ECG files from Mortara ECG carts using DICOM interface, the Horizon Cardiology ECG Management System does not display the amplitudes of the waveform properly.
FDA Determined
Cause 2
DESIGN: Device Design
Action McKesson Medical sent an advisory notice letter dated June 16, 2010, to all affected customers. Advisory notice ADV01646 was distributed to 13 affected clinical sites from August 30, 2010 to September 28, 2010. The letters identified the product that is affected, the circumstances under which patient safety issue may occur, the risk, and the immediate actions that need to be taken along with a temporary fix. Customers were instructed to use the ECG cart printout to verify results of procedures acquired by Mortara ECG carts. Users should be aware of the problem when referrring to past ECG procedures and when performing a visual comparison with ECG procedures acquired by Mortara ECG carts. Customers should disable the Glasgow Serial Comparison for ECG procedures. McKesson Support would contact the customer to coordinate the deployment of the software update on all the affected applications and Horizon Cardiology client applications. For any questions regarding this recall, customers should call the Customer Support department at 1-866-777-0202 and speak to their Support Manager.
Quantity in Commerce 16 units
Distribution Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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