Z-0710-2008

Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50...

Name: Z-0710-2008 Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50...
Creator: McKesson Provider Technologies
Published: 2007-11-12
License: https://open.fda.gov/license/

Change Healthcare Technologies LLC / initiated 2007-11-12 / Terminated / root cause: manufacturing process

FDA source

McKesson Provider Technologies began a recall of Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv... on 2007-11-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0710-2008
Status: Terminated
Initiated: 2007-11-12
Posted: 2008-02-05
Terminated: 2008-05-28
Recalling firm: Change Healthcare Technologies LLC
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: manufacturing process
FDA root cause: 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,
Product codes and lots: 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

Product code DQK

K050561Class IIWindsurferMedcon , Ltd. / cleared 2005-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)