Recall Z-1490-2019 ยท DQK Computer, Diagnostic, Programmable
Change Healthcare Israel Ltd.
McKesson Cardiology Hemo
| Date | Mar 25, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software Design Change |
| Action | Change Healthcare notified consignees on about 03/25/2019 via "Urgent Field Safety Notice" letter sent through email. The notification informed consignees that the issue can occur under the following 3 circumstances: 1. When a user intentionally updates the Physician Report, overriding procedure medication derived from the Hemo report, or 2. When a user intentionally updates the medication information charted for Pre- or Intra- procedure stage, from the Intra- or Post-procedure stage (respectively), or 3. Due to an unexpected system error. Instructions included that prior to closing a Hem |
| Quantity | 1,383 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131497 | MCKESSON CARDIOLOGY HEMO Mckesson Israel , Ltd., Dec 5, 2013 |