CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Change Healthcare Cardiology Hemodynamics recalled by A L I Technologies
A L I Technologies is recalling Change Healthcare Cardiology Hemodynamics, distributed nationwide in the US. The recall was initiated on 2 Dec 2024 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-0959-2025
- FDA event ID
- 96025
- Recalling firm
- A L I Technologies, Burnaby
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 2 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +45 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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
US 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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Which lots are affected?
Software version 15.01/UDI:(01)17540262100129
Where was it sold?
US 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.
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
2 other products · FDA event 96025This product is part of a recall event; the main page for the event is Change Healthcare Cardiology Hemo recalled by A L I Technologies.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Change Healthcare Cardiology Hemo recalled by A L I Technologies | A L I Technologies | Device Malfunction | Nationwide | |
| CLASS II | McKesson Cardiology Hemo recalled by A L I Technologies | A L I Technologies | Device Malfunction | Nationwide |
More recalls from A L I Technologies
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Cardiology Hemo recalled by A L I Technologies | A L I Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled by A L I Technologies | A L I Technologies | Device Malfunction | Nationwide |
Other Medical Software recalls
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|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |