CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Change Healthcare Radiology Solutions recalled
Change Healthcare Canada is recalling Change Healthcare Radiology Solutions, distributed nationwide in the US. The recall was initiated on 13 Aug 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-0030-2026
- FDA event ID
- 97545
- Recalling firm
- Change Healthcare Canada, Richmond, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Aug 2025
- FDA classified
- 2 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 13 Aug 2025 | Recall initiated by company | |
| 2 Oct 2025 | Classified by FDA | +50 days |
| 8 Oct 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
Due to software issue, radiology reports may not be fully displayed when viewing.
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 Radiology Solutions software version 14.2.2
Where it was distributed
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Nationwide AlabamaArkansasCaliforniaFloridaIndianaLouisianaMassachusettsNew JerseyWashingtonWisconsin
Questions about this recall
Why was it recalled?
Due to software issue, radiology reports may not be fully displayed when viewing.
Which lots are affected?
Version 14.2.2/UDI: (01)17540262030068
Where was it sold?
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
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.
More recalls from Change Healthcare Canada
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|---|---|---|---|---|---|
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemodynamics 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 |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |