ClearanceBrief
Recall Z-0710-2008 ยท DQK Computer, Diagnostic, Programmable

McKesson Provider Technologies

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.

DateFeb 5, 2008 (initiated Nov 12, 2007)
StatusTerminated
ReasonPower 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.
Root causeNonconforming Material/Component
ActionRecalled 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.
Quantity13
DistributionNationwide to hospital and medical centers in LA. CA, PA and IL,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050561WINDSURFER
Medcon , Ltd., May 4, 2005