CLASS II ONGOING Device recall · Reported 5 May 2021 · FDA Enforcement Report

Change Healthcare Enterprise Viewer recalled

Change Healthcare Canada is recalling Change Healthcare Enterprise Viewer, distributed in 17 states. The recall was initiated on 17 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesChange Healthcare Enterprise Viewer 2.0 and 2.1

Quantity recalled28 units

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-1508-2021
FDA event ID: 87616
Recalling firm: Change Healthcare Canada, Richmond, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 17 Mar 2021
FDA classified: 28 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 Mar 2021	Recall initiated by company
28 Apr 2021	Classified by FDA	+42 days
5 May 2021	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

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

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 Enterprise Viewer

Where it was distributed

Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA

Alaska Arizona California Florida Hawaii Iowa Illinois Kentucky Michigan Nebraska New York Ohio Pennsylvania Texas Washington Wisconsin Wyoming

Questions about this recall

Why was it recalled?

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

Which lots are affected?

Change Healthcare Enterprise Viewer 2.0 and 2.1

Where was it sold?

Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA

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

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide