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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 Data Export Failure

Agency Publication Date: February 28, 2025
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Summary

Philips Medical Systems is recalling 139 units of its IntelliSpace Cardiovascular software (Model 830089, version 7.0.0.0) because the system is unable to archive, copy, or export study data. This defect prevents healthcare providers from properly saving or transferring patient cardiovascular records to other systems. No injuries or incidents have been reported, but the manufacturer has voluntarily initiated the recall to address these software failures.

Risk

The inability to export or archive cardiovascular study data may lead to the loss of critical patient information or delays in diagnosis and treatment if the data is not available when and where it is needed for clinical decision-making.

What You Should Do

  1. This recall affects Philips IntelliSpace Cardiovascular software, Model 830089, specifically software version 7.0.0.0 with UDI (01)00884838115378(11)221214(10)7.0.0.0.
  2. Stop using the recalled software. Contact Philips Medical Systems Nederland B.V. or your equipment distributor to arrange for a software correction, update, or replacement.
  3. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have questions about medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Software correction or replacement

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Philips IntelliSpace Cardiovascular software
Variants: Software version 7.0.0.0
Model / REF:
830089
UDI:
(01)00884838115378(11)221214(10)7.0.0.0

Recall number Z-1252-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96129
Status: Active
Manufacturer: Philips Medical Systems Nederland B.V.
Sold By: Government distribution; Medical facilities
Manufactured In: Netherlands
Units Affected: 139
Distributed To: Alaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Virginia, Wisconsin

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.