FDA Medical Device Recalls (openFDA)
Change Healthcare Israel Ltd.: Horizon Cardiology Hemo
- Recall number
- Z-1489-2019
- Recalling firm
- Change Healthcare Israel Ltd.
- Product
- Horizon Cardiology Hemo
- Status
- Terminated
- Initiated
- 2019-03-25
- Posted
- not on file
- Terminated
- 2025-03-04
- 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 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
- 125 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.
- Lot, serial or model codes
- Software version 11.x and 12.x
- 510(k) numbers
- ["K131497"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3007784465
- Firm city
- Holon
- Firm state
- Ha-Rokmim
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28