CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Change Healthcare Cardiology Hemodynamics recalled
Change Healthcare Canada is recalling Change Healthcare Cardiology Hemodynamics, distributed nationwide in the US. The recall was initiated on 22 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2072-2025
- FDA event ID
- 97046
- Recalling firm
- Change Healthcare Canada, Richmond
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 2 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 22 May 2025 | Recall initiated by company | |
| 2 Jul 2025 | Classified by FDA | +41 days |
| 9 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to complaints, software update may cause software to unexpectedly shutdown.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Change Healthcare Cardiology Hemodynamics Software
Where it was distributed
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.
Nationwide AlabamaArkansasCaliforniaFloridaKentuckyMissouriMississippiNebraskaNew HampshireNew JerseyPennsylvaniaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Due to complaints, software update may cause software to unexpectedly shutdown.
Which lots are affected?
Software version: 15.0.1/UDI: (01)17540262100129
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97046| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
More recalls from Change Healthcare Canada
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Change Healthcare Radiology Solutions recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Labeling Errors | Nationwide |
| Device | CLASS II | Horizon Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |