Recall – Hemodynamic monitoring system report discrepancies

Company: Change Healthcare Israel Ltd.
Date of Enforcement Report: 6/5/2019
Class II

PRODUCT

Horizon Cardiology Hemo:

Software version 11.x and 12.x

Recall Number: Z-1489-2019

Software version 13.x

Recall Number: Z-1490-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Change Healthcare Israel Ltd. on 3/25/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
125 devices

DISTRIBUTION

US Nationwide and International

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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