Skip to content
Lower risk Medical device recall · FDA · Published August 8, 2025

Philips IntelliSpace Cardiovascular Software 8.0.0.4 Shows Outdated Info

Philips recalls IntelliSpace Cardiovascular software version 8.0.0.4 due to outdated information display. Affected units may show incorrect data during medical procedures.

🇺🇸 FDA recall #Z-2543-2025Medical devicePhilips ›
Take action

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Philips is recalling a specific software version for its IntelliSpace Cardiovascular system because it displays outdated information. This could lead to incorrect medical decisions if the software is used in clinical settings. Read more at govinfonow.com/recall/51651-philips-intellispace-cardiovascular-software-8-0-0-4-shows-outdated.

Source Summary by GovInfoNow · govinfonow.com/recall/51651-philips-intellispace-cardiovascular-software-8-0-0-4-shows-outdated · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2543-2025

Cite this page

“Philips IntelliSpace Cardiovascular Software 8.0.0.4 Shows Outdated Info.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51651-philips-intellispace-cardiovascular-software-8-0-0-4-shows-outdated. Based on FDA recall #Z-2543-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2025%22&limit=1).

Why it’s dangerous

The software displays outdated information, which could lead to incorrect medical decisions if used in clinical settings. This might affect patient safety during procedures requiring precise data.

Who’s affected

Healthcare providers using the IntelliSpace Cardiovascular software version 8.0.0.4 are most at risk. Patients receiving care from these systems may be affected if the outdated information causes errors.

How to tell if you have this one

Check for the software version 8.0.0.4 on the IntelliSpace Cardiovascular system. The model number is 830089, and serial numbers include 2210, 2050, 463, 193.

  • Brand
    Philips
  • Product
    IntelliSpace Cardiovascular, Software 8.0.0.4
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your IntelliSpace Cardiovascular system to see if it is 8.0.0.4.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of GA, NC & TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Georgia, North Carolina, Texas.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Aug 8, 202512. FDA classified it Class II: Sep 9, 202523. Published in FDA’s Enforcement Report: Sep 17, 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.

Similar recalls

Latest medical device recalls

Keep exploring

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-2543-2025 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2543-2025 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