Mckesson Cardiology Hemo

• • Ongoing Z-2071-2025 FDA Class II ·initiated 22 May 2025

  Due to complaints, software update may cause software to unexpectedly shutdown.

• 2 recalls, same reason

  • Ongoing Z-0957-2025 FDA Class II ·initiated 2 Dec 2024
  • Ongoing Z-0958-2025 FDA Class II ·initiated 2 Dec 2024

  Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

• 2 recalls, same reason

  • Ongoing Z-0128-2025 FDA Class II ·initiated 21 Aug 2024 ·on shared 510(k) K131497
  • Ongoing Z-0126-2025 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.

• 2 recalls, same reason

  • Terminated Z-1489-2019 FDA Class II ·initiated 25 Mar 2019 ·on shared 510(k) K131497
  • Terminated Z-1490-2019 FDA Class II ·initiated 25 Mar 2019 ·on shared 510(k) K131497

  users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.

• • Terminated Z-2968-2018 FDA Class II ·initiated 12 Mar 2018 ·on shared 510(k) K131497

  Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.

• • Terminated Z-0042-2015 FDA Class II ·initiated 27 Aug 2014

  Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.

• • Terminated Z-0093-2015 FDA Class II ·initiated 25 Jun 2014

  McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K131497 ↗

FDA Product Code

MWI

FDA applicant

Mckesson Israel , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Horizon Cardiology ECG Management Open recall

  Class II

  FDA 510(k) K113515 Active Cleared 16 Mar 2012

• Mckesson Cardiology ECG Mobile

  Class II

  FDA 510(k) K133534 Active Cleared 18 Apr 2014

• Mckesson Horizon Cardiology

  Class II

  FDA 510(k) K112720 Active Cleared 30 Jan 2012

• McKesson Cardiology

  Class II

  FDA 510(k) K151850 Active Cleared 11 Aug 2015