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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 Recall
Horizon Cardiology Hemo Monitoring System
see related information
Date Posted February 05, 2008
Recall Status1 Terminated on May 28, 2008
Recall Number Z-0710-2008
Recall Event ID 46276
Premarket Notification
510(K) Number
K050561 
Product Classification Computer, Diagnostic, Programmable - 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/
Manufacturer
McKesson Provider Technologies
628 State Route 10
Whippany, New Jersey 07981-1522
For Additional Information Contact Ronen Gans
973-884-0203
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = MEDCON LTD.
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