Philips Medical Systems Nederland B.V. 2025-05-14 Health serious FDA
Health · FDA · Recall #FDA-Z-1740-2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Recall
Issued May 14, 2025 · Philips Medical Systems Nederland B.V.
In May 2025, Philips Medical Systems Nederland B.V. recalled the IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips Medical Systems Nederland B.V. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips Medical Systems Nederland B.V.
- Category
- Health
- Recall date
- May 14, 2025
- Units affected
- Not reported
- Sold at
- Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, H
- Recall number
- FDA-Z-1740-2025
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- Philips Medical Systems Nederland B.V. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.