Class 2 Device Recall McKesson Cardiology Hemo

• Date Initiated by Firm: March 25, 2019
• Create Date: May 24, 2019
• Recall Status: Completed
• Recall Number: Z-1490-2019
• Recall Event ID: 82600
• 510(K)Number: K131497
• Product Classification: Computer, diagnostic, programmable - Product Code DQK
• Product: McKesson Cardiology Hemo
• Code Information: Software version 13.x
• Recalling Firm/ Manufacturer: Change Healthcare Israel Ltd.; 26, Ha-Rokmim; Holon Israel
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = DQK and Original Applicant = MCKESSON ISRAEL LTD.