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Lower risk Medical device recall · FDA · Published April 4, 2024

Philips IntelliSpace Cardiovascular Software Recall: Data Not Archivable

Philips recalls software version 7.0.0.0 (UDI 0100884838115378) due to inability to archive, copy, or export study data. Affected users should contact Philips for details.

🇺🇸 FDA recall #Z-1252-2025Medical devicePhilips ›
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Contact the company

Recalling firmPhilips Medical Systems Nederland B.V.High Tech Campus 36 · Eindhoven, Netherlands
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling a specific version of its IntelliSpace Cardiovascular software because it cannot properly save, copy, or export study data. This could lead to lost medical records and affect patient care. Read more at govinfonow.com/recall/55668-philips-intellispace-cardiovascular-software-recall-data-not-archivable.

Source Summary by GovInfoNow · govinfonow.com/recall/55668-philips-intellispace-cardiovascular-software-recall-data-not-archivable · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1252-2025

Cite this page

“Philips IntelliSpace Cardiovascular Software Recall: Data Not Archivable.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55668-philips-intellispace-cardiovascular-software-recall-data-not-archivable. Based on FDA recall #Z-1252-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1252-2025%22&limit=1).

Why it’s dangerous

The software version 7.0.0.0 fails to archive, copy, or export study data, which means medical records could be lost. This might impact patient care and compliance with medical data standards.

Who’s affected

Healthcare professionals using Philips IntelliSpace Cardiovascular software version 7.0.0.0 with UDI 0100884838115378 are likely affected. Patients using this software for medical imaging may be at risk of data loss.

How to tell if you have this one

Check for software version 7.0.0.0 with UDI 0100884838115378 on Philips IntelliSpace Cardiovascular systems. This version was sold starting in 2022.

  • Brand
    Philips
  • Product
    Philips IntelliSpace Cardiovascular software, Model 830089
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version is 7.0.0.0 with UDI 0100884838115378.

  2. Contact Philips

    Reach out to Philips for guidance on updating or replacing the software.

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: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, California, Connecticut, Florida, Georgia, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Nebraska, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 11 months after the firm started it.

1. Firm started the recall: Apr 4, 202412. FDA classified it Class II: Feb 28, 202523. Published in FDA’s Enforcement Report: Mar 12, 2025320242025
  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-1252-2025 (April 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1252-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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