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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Cardiology Hemo Monitoring System

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  Class 2 Device Recall Horizon Cardiology Hemo Monitoring System see related information
Date Initiated by Firm November 12, 2007
Date Posted February 05, 2008
Recall Status1 Terminated 3 on May 28, 2008
Recall Number Z-0710-2008
Recall Event ID 46276
510(K)Number k050561  
Product Classification Programmable Diagnostic Computer - Product Code DQK
Product Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC
50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Code Information Serial Numbers of subassemblies (ECUs) that contain the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210, A0225, A0232, A0233, A0234, A0235, and A0236
Recalling Firm/
McKesson Provider Technologies
628 State Route 10
Whippany NJ 07981-1522
For Additional Information Contact Ronen Gans
Manufacturer Reason
for Recall
Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.
Quantity in Commerce 13
Distribution Nationwide to hospital and medical centers in LA. CA, PA and IL,
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 = DQK and Original Applicant = MEDCON LTD.