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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare Cardiology Hemodynamics

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 Class 2 Device Recall Change Healthcare Cardiology Hemodynamicssee related information
Date Initiated by FirmMay 22, 2025
Date PostedJuly 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2072-2025
Recall Event ID 97046
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: 15.0.1/UDI: (01)17540262100129
FEI Number 3003757840
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
Manufacturer Reason
for Recall		Due to complaints, software update may cause software to unexpectedly shutdown.
FDA Determined
Cause 2		Software design
ActionOn May 22, 2025, Change Healthcare issued a "Urgent Field Safety notice" to affected consignees via e-mail. On May June 11, 2025, Change Healthcare sent out an updated notification providing additional information. Change Healthcare asked consignees to take the following actions: 1. Change Healthcare has developed a software update that addresses this issue. Contact Change Healthcare support to schedule its deployment. 2. This notice must be distributed to all personnel within your organization who need to be aware of this notice. Customers should alert other affiliated parties that may be affected by this notice. 3. 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.
Quantity in Commerce4 systems
DistributionWorldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
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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