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Use caution Medical device recall · FDA · Published May 22, 2025

Change Healthcare Cardiology Software Update May Cause Unexpected Shutdowns

Change Healthcare recalls cardiology hemodynamics software version 15.0.1 due to unexpected shutdowns. Affected users should stop using the software immediately.

🇺🇸 FDA recall #Z-2072-2025Medical 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 cardiology hemodynamics software version 15.0.:17540262100129 due to unexpected shutdowns. This could disrupt medical monitoring and cause errors in patient care. Read more at govinfonow.com/recall/52229-change-healthcare-cardiology-software-update-may-cause-unexpected-shutdowns.

Source Summary by GovInfoNow · govinfonow.com/recall/52229-change-healthcare-cardiology-software-update-may-cause-unexpected-shutdowns · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2072-2025

Cite this page

“Change Healthcare Cardiology Software Update May Cause Unexpected Shutdowns.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52229-change-healthcare-cardiology-software-update-may-cause-unexpected-shutdowns. Based on FDA recall #Z-2072-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2072-2025%22&limit=1).

Change Healthcare Canada Company voluntarily recalled Change Healthcare Cardiology Hemodynamics Software on May 22, 2025, according to the FDA. The software may unexpectedly shut down due to a software update issue.

How to tell if you have it

  • Brand: Change Healthcare
  • Product: Change Healthcare Cardiology Hemodynamics Software
  • Version: 15.0.1
  • UDI: (01)17540262100129
  • UPC: 17540262100129

The hazard

The recall was issued because a software update may cause the software to unexpectedly shut down, according to complaints received by the company.

Context

GovInfoNow's records show Change Healthcare Canada Company has had eight other recalls since February 10, 2020. Other recent recalls of similar products include GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026) and GE HealthCare APEXPRO v5.0 Software Risk (April 24, 2026).

How to tell if you have this one

Check if you have the software version 15.0.1 with UDI: (01)17540262100129. The software is used by healthcare providers for cardiology hemodynamics monitoring.

  • Brand
    Change Healthcare
  • Product
    Change Healthcare Cardiology Hemodynamics Software
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
Recall numberProduct, codes & lotsQuantity
Z-2071-2025Change Healthcare Cardiology Hemo Software; Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)1754026210010529 systems
Z-2072-2025Change Healthcare Cardiology Hemodynamics Software; Software version: 15.0.1/UDI: (01)175402621001294 systems
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Software

    Immediately stop using the affected software version 15.0.1/UDI: (01)17540262100129 to prevent unexpected shutdowns.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 14 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, California, Florida, Kentucky, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: May 22, 202512. FDA classified it Class II: Jul 2, 202523. Published in FDA’s Enforcement Report: Jul 9, 202532025
  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.

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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-2072-2025 (May 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2072-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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