Food, drugs, devices › CHANGE HEALTHCARE CANADA COMPANY
Device recall: Change Healthcare Cardiology Hemo Software
FDA enforcement event 97046 is a device recall by CHANGE HEALTHCARE CANADA COMPANY of Richmond, initiated 22 May 2025 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. CHANGE HEALTHCARE CANADA COMPANY has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CHANGE HEALTHCARE CANADA COMPANY, Richmond, Canada.
Reason for recall
"Due to complaints, software update may cause software to unexpectedly shutdown."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2071-2025 | Change Healthcare Cardiology Hemo Software | 29 systems | Class II | Ongoing | 9 Jul 2025 |
| Z-2072-2025 | Change Healthcare Cardiology Hemodynamics Software | 4 systems | Class II | Ongoing | 9 Jul 2025 |
Context
Other enforcement events for CHANGE HEALTHCARE CANADA COMPANY
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Aug 2025 | Change Healthcare Radiology Solutions software version 14.2.2 | Device | Class II | 1 |
| 21 Aug 2024 | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. | Device | Class II | 3 |
| 1 Nov 2023 | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. | Device | Class II | 1 |
| 12 Oct 2023 | Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management s | Device | Class II | 1 |
| 19 Apr 2021 | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D d | Device | Class II | 1 |
| 17 Mar 2021 | Change Healthcare Enterprise Viewer | Device | Class II | 1 |
| 25 Aug 2020 | Change Healthcare Radiology Solutions 14.0 | Device | Class II | 1 |
| 10 Feb 2020 | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | Device | Class II | 1 |
All 9 events for CHANGE HEALTHCARE CANADA COMPANY
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to complaints, software update may cause software to unexpectedly shutdown."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.