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