Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntelliSpace Cardiovascular software versions 6.x Recalled by Philips Medical Systems Nederland B.V. Due to An issue was identified with the software when...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems Nederland B.V. directly.
Affected Products
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Quantity: 996 units (267 US, 729 OUS)
Why Was This Recalled?
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report