Windsurfer

510(k) K050561

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK050561	Date4 May 2005Cleared	StatusActive

4 recalls · 1 ongoing · FDA

- Ongoing Z-0127-2025 FDA Class II initiated 21 Aug 2024
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
- Terminated Z-1974-2010 FDA Unclassified (pre-2012) initiated 15 Apr 2010
McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cariology Hemo Real Time Monitor Screen.
- Terminated Z-1899-2010 FDA Unclassified (pre-2012) initiated 27 Jan 2010
McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.
- Terminated Z-0710-2008 FDA Unclassified (pre-2012) initiated 12 Nov 2007
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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)