Recall Z-2072-2025 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemodynamics Software
| Date | Jul 2, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| Reason | Due to complaints, software update may cause software to unexpectedly shutdown. |
| Root cause | Software design |
| Action | On 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 |
| Quantity | 4 systems |
| Distribution | Worldwide - 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230881 | Change Healthcare Cardiology Hemodynamics™ Change Healthcare Israel , Ltd., Sep 11, 2023 |