FDA-Device2019-06-05Class II
McKesson Cardiology Hemo
Change Healthcare Israel Ltd.
Hazard
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.
Sold states
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.
Affected count
1,383 devices
Manufactured in
26, Ha-Rokmim, N/A, Holon, N/A, Israel
Products
McKesson Cardiology Hemo
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2019Don't want to check this manually?
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