Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1490-2019 — McKesson Cardiology Hemo

U.S. FDA — Device Enforcement · Israel · 2019-03-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1490-2019
Date of alert
2019-03-25
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Change Healthcare Israel Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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