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Lower risk Medical device recall · FDA · Published April 19, 2021

Change Healthcare Enterprise Viewer Software Defect: Images Not Displaying Correctly

Change Healthcare recalls Enterprise Viewer software versions 2.0 and 2.1 due to image display issues. Affected users should check their software version and contact the manufacturer for updates.

🇺🇸 FDA recall #Z-1773-2021Medical deviceChange Healthcare ›
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Contact the company

Recalling firmCHANGE HEALTHCARE CANADA COMPANY10711 Cambie Rd Suite 130 · Richmond, Canada
✎ GovInfoNow plain-language explainer

Change Healthcare is recalling its Enterprise Viewer software versions 2.0 and 2.1 because a defect prevents medical images from displaying correctly. This could lead to incorrect medical information being used in healthcare settings. Read more at govinfonow.com/recall/62765-change-healthcare-enterprise-viewer-software-defect-images-not-displaying-correctly.

Source Summary by GovInfoNow · govinfonow.com/recall/62765-change-healthcare-enterprise-viewer-software-defect-images-not-displaying-correctly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1773-2021

Cite this page

“Change Healthcare Enterprise Viewer Software Defect: Images Not Displaying Correctly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62765-change-healthcare-enterprise-viewer-software-defect-images-not-displaying-correctly. Based on FDA recall #Z-1773-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2021%22&limit=1).

Change Healthcare Canada Company recalled Change Healthcare Enterprise Viewer software versions 2.0 and 2.1 on April 19, 2021, according to the FDA. The recall addresses a defect where image styles defined by presentation states are not displayed correctly.

How to tell if you have it

  • Brand: Change Healthcare
  • Product: Change Healthcare Enterprise Viewer
  • Versions: 2.0 and 2.1
  • Quantity: 33 devices

The hazard

A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

Context

GovInfoNow's records show Change Healthcare Canada Company has 8 other recalls on record since Feb. 10, 2020. Other recent recalls of similar products include Change Healthcare Radiology Software Version 14.2.2 (Aug. 13, 2025), Change Healthcare Cardiology Software Update (May 22, 2025), and Change Healthcare Cardiology Hemo Software Recall (Aug. 21, 2024).

How to tell if you have this one

Check if your software version is 2.0 or 2.1. The product is intended for use with off-the-shelf hardware for 2D and 3D medical imaging displays.

  • Brand
    Change Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Determine if your Enterprise Viewer software is version 2.0 or 2.1.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 22 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, Arkansas, California, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Mississippi, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Apr 19, 202112. FDA classified it Class II: Jun 2, 202123. Published in FDA’s Enforcement Report: Jun 9, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this defect?

The recall states a software defect causing image display issues, but no specific risk of injury is mentioned. The danger level is low_risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1773-2021 (April 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1773-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA