IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Summary
The FDA issued a Class II for IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8 by Philips Medical Systems Nederland B.V.. Reason: 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..
Details
Source
Device Recall
External ID
Z-1740-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Lot/Code Info: Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).
Quantity Affected: 996 units (267 US, 729 OUS)
Reason for Recall
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.
Distribution
Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-07
Company
Eindhoven, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Medical Systems Nederland B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Medical Systems Nederland B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Medical Systems Nederland B.V. have FDA actions?
Philips Medical Systems Nederland B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1740-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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