Holon, N/A, Israel
Change Healthcare Israel Ltd. recalls
1 recall recorded since 2018, most recently on 25 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 March 2019
- Terminated
- 4 March 2025
- 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.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1490-2019, Z-1489-2019
- McKesson Cardiology Hemo
- Horizon Cardiology Hemo
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.