Change Healthcare Israel Ltd. recalls Horizon Cardiology Hemo

Recall date

March 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1489-2019

FDA classification

Class II

Brand / firm

Change Healthcare Israel Ltd.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Horizon Cardiology Hemo