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.
FDA Recall Z-0710-2008 · Posted 2008-02-05
Recalling FirmMcKesson Provider Technologies
Recall StatusTerminated
Product CodeDQK
Date Initiated2007-11-12
Date Terminated2008-05-28
Product Quantity13
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide to hospital and medical centers in LA. CA, PA and IL,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.