Z-1490-2019Class II

McKesson Cardiology Hemo

Name: Z-1490-2019 McKesson Cardiology Hemo
Creator: Change Healthcare Israel Ltd.
Published: 2019-03-25
License: https://open.fda.gov/license/

Change Healthcare Israel Ltd. / initiated 2019-03-25 / Terminated / root cause: software

FDA source

Change Healthcare Israel Ltd. began a recall of McKesson Cardiology Hemo on 2019-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1490-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-25
Posted: 2019-05-24
Terminated: 2025-03-04
Recalling firm: Change Healthcare Israel Ltd.
Product: McKesson Cardiology Hemo
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: software
FDA 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 Hemo case, ensure the list of administered medication information is correct on the Vitals and Meds, Procedure Notes, and Patient Common Data screens, and when opening, finalizing or closing the Physician Report, review the procedure medications to ensure that all medication information is correct. Customers were requested to immediately contact Change Healthcare to acknowledge they have read and understand the Urgent Field Safety Notice and to arrange for installation of the software update/upgrade. They were also requested to ensure distribution of the Urgent Field Safety Notice to all personnel within your organization who should be aware of the recall or to other affiliated parties that may be affected by the Urgent Field Safety Notice. Customer Support contacts are as follows: 1. US/Canada: 1-877-654-4366; 2. UK / Ireland: +44 (0) 208 9527399; 3. Australia: 1800 625 435; 4. Israel: +972 52 433 3366
Quantity in commerce: 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.
Product codes and lots: Software version 13.x

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1490-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1489-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-24
Z-1490-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-24

Product code DQK

K131497Class IIMckesson Cardiology HemoMckesson Israel , Ltd. / cleared 2013-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)