Change Healthcare Israel Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1489-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Horizon Cardiology Hemo

Product Classification:

Class II

Date Initiated: March 25, 2019

Date Posted: June 5, 2019

Recall Number: Z-1489-2019

Event ID: 82600

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.

Status: Terminated

Product Quantity: 125 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated