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Class 2 Device Recall Horizon Cardiology ECG Management |
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Date Initiated by Firm |
June 16, 2010 |
Date Posted |
January 13, 2011 |
Recall Status1 |
Terminated 3 on August 17, 2012 |
Recall Number |
Z-0900-2011 |
Recall Event ID |
57436 |
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
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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 NJ 07054-4506
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For Additional Information Contact |
Rick Gary 973-355-9900
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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.
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FDA Determined Cause 2 |
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
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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.
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