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U.S. Department of Health and Human Services

Class 2 Device Recall hange Healthcare Cardiology Hemodynamics

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 Class 2 Device Recall hange Healthcare Cardiology Hemodynamicssee related information
Date Initiated by FirmDecember 02, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0959-2025
Recall Event ID 96025
510(K)NumberK230881 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductChange Healthcare Cardiology Hemodynamics software
Code Information Software version 15.01/UDI:(01)17540262100129
Recalling Firm/
Manufacturer		 A L I Technologies Ltd
3700 Gilmore Way Suite 207
Burnaby Canada
Manufacturer Reason
for Recall		Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
FDA Determined
Cause 2		Software design
ActionOn 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 corrective actions, please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved. 4. Please notify our Customer Support department that you have read and understood this field safety notice, and if you want the product update to be installed on your system. Customer Support number by region: US / Canada: 1 877 654 4366 5. Once again, until the product update is installed at your site, Change Healthcare recommends that the immediate actions (described above) be taken.
Quantity in Commerce2 units
DistributionUS 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.
Total Product Life CycleTPLC 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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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