CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Change Healthcare Radiology Solutions recalled

Change Healthcare Canada is recalling Change Healthcare Radiology Solutions 14.0, distributed in Mississippi, Nebraska, Vermont, West Virginia. The recall was initiated on 25 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Model number 14.0 UDI (01)17540262030020(10)140000

Quantity recalled5 devices

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-0072-2021
FDA event ID: 86401
Recalling firm: Change Healthcare Canada, Richmond, N/A
Classification: Class II
Status: Terminated
Recall initiated: 25 Aug 2020
FDA classified: 8 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

25 Aug 2020	Recall initiated by company
8 Oct 2020	Classified by FDA	+44 days
14 Oct 2020	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 which may potentially result in one or more images missing in a study

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 14.0

Where it was distributed

Domestic distribution to VT, MS, WV, NE

Mississippi Nebraska Vermont West Virginia

Questions about this recall

Why was it recalled?

Software defect which may potentially result in one or more images missing in a study

Which lots are affected?

All Model number 14.0 UDI (01)17540262030020(10)140000

Where was it sold?

Domestic distribution to VT, MS, WV, NE

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

All 12

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Device	CLASS II	Change Healthcare Radiology Solutions recalled	Change Healthcare Canada	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS II	Change Healthcare Cardiology Hemo recalled	Change Healthcare Canada	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS II	Change Healthcare Cardiology Hemodynamics recalled	Change Healthcare Canada	Device Malfunction	Nationwide
23 Oct 2024Device	CLASS II	McKesson Cardiology Hemo recalled by Change Healthcare Canada	Change Healthcare Canada	Labeling Errors	Nationwide
23 Oct 2024Device	CLASS II	Change Healthcare Cardiology Hemo recalled	Change Healthcare Canada	Labeling Errors	Nationwide

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