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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips IntelliSpace Cardiovascular Software Recalled for Outdated Information

Agency Publication Date: September 9, 2025
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Summary

Philips Medical Systems Nederland B.V. has recalled four units of IntelliSpace Cardiovascular software (version 8.0.0.4.) due to a software issue that causes the system to display outdated information. This recall affects Model No. 830089 with specific serial numbers 2210, 2050, 463, and 193. Because this is a clinical diagnostic tool, clinicians should immediately consult with their facility's IT or laboratory supervisor to manage software corrections.

Risk

The software issue can result in the display of outdated patient data during cardiovascular assessments. This could potentially lead to clinical staff making diagnostic or treatment decisions based on incorrect information, which may impact patient safety.

What You Should Do

  1. This recall affects Philips IntelliSpace Cardiovascular software version 8.0.0.4 (Model No. 830089). Affected units carry serial numbers 2210, 2050, 463, and 193.
  2. Stop using the recalled software immediately for patient diagnostics.
  3. Contact Philips Medical Systems Nederland B.V. or your equipment distributor to arrange for a software correction, update, or replacement.
  4. Call the FDA at 1-888-463-6332 for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IntelliSpace Cardiovascular (Software 8.0.0.4.)
Variants: Software version 8.0.0.4.
Model / REF:
830089
Serial Numbers:
2210
2050
463
193
UDI:
(01)00884838122000(11)240325(10)8.0.0.0

Software issue results in the display of outdated information.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97379
Status: Active
Manufacturer: Philips Medical Systems Nederland B.V.
Sold By: Clinical software distributors; Philips Medical Systems
Manufactured In: Netherlands
Units Affected: 4 units
Distributed To: Georgia, North Carolina, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.