Recall Z-1489-2019— Change Healthcare Israel Ltd.

Name: FDA recall Z-1489-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-25

Class II · Terminated

Class II FDA medical device recall by Change Healthcare Israel Ltd., initiated 2019-03-25, terminated 2025-03-04. It names one FDA 510(k) clearance: K131497. Product: Horizon Cardiology Hemo. 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: Change Healthcare Israel Ltd.
Classification: Class II
Status: Terminated
Initiated: 2019-03-25
Terminated: 2025-03-04
Firm location: Holon, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K131497 — MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd.·cleared 2013-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Horizon Cardiology Hemo

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.