Recall Z-0958-2025 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
| Date | Jan 16, 2025 (initiated Dec 2, 2024) |
| Status | Open, Classified |
| Reason | Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). |
| Root cause | Software design |
| Action | On December 2, 2024 Change Healthcare Canada Company issued a "Urgent Field Safety" Recall Notice to affected consignees. Change Healthcare Canada Company ask consignees to take the following actions: 1. Please contact and work with our Customer Support team to identify and correct any potentially affected data. 2. This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. 3. To ensure effectiveness of any required c |
| Quantity | 204 units |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, 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 |