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Recall Observatory FDA recall evidence

Device product

Horizon Cardiology Hemo

Z-1489-2019

March 25, 2019

Class II

Product summary

Firm
Change Healthcare Israel Ltd.
Event
Event 82600
Status
Terminated
Classification
Class II
Quantity
125 devices
Official record key
device-enforcement:Z-1489-2019

Official wording

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.

Code information: Software version 11.x and 12.x

Distribution pattern: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WY. International distribution to Australia, Canada, Germany, Ireland, Israel, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.