Z-1490-2019 Class II Terminated
FDA device recall Z-1490-2019 was initiated by Change Healthcare Israel Ltd. on March 25, 2019 and is designated Class II. 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 discrepa… The recall status is terminated (terminated March 4, 2025). Affected quantity: 1,383 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- March 25, 2019
- Termination Date
- March 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,383 devices
Product Description
McKesson Cardiology Hemo
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.
Distribution Pattern
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.
Code Information
Software version 13.x