IntelliSpace Cardiovascular Software Echo Module Data Reporting Issue
Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source is a Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is incomplete or missing data in reports—a significant functional defect but not a direct patient safety threat, warranting a Moderate classification.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling IntelliSpace Cardiovascular (ISCV) software versions 6.x, 7.x, and 8.x (Model Number 830089) distributed domestically nationwide and internationally to multiple countries. An issue was identified with the software when using the Echo Module; the issue may result in missing or incomplete information in the report.
A total of 996 units have been distributed: 267 in the United States and 729 outside the United States. The affected software versions are identified by specific UDI-DIs and version numbers, including 6.1.0.0, 6.2.0.0, 7.0.0.0, 7.1.0.0, and 8.0.0.0.
Users should contact Philips Medical Systems Nederland B.V. for guidance on whether their systems are affected and for instructions on remediation or replacement.
The recalled product
- Product
- IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
- Manufacturer
- Philips Medical Systems Nederland B.V.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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).
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Medical Systems Nederland B.V.
See all →- HighPhilips Azurion Rystem X-Ray System Software Recall for Image Quality Issues
FDA (Devices) · 2026-08-19
- HighPhilips Azurion Fluoroscopy System Recall for Software Image Quality Issues
FDA (Devices) · 2026-08-19
- HighPhilips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue
FDA (Devices) · 2026-08-19
- SeverePhilips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
FDA (Devices) · 2026-08-12
- HighPhilips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures
FDA (Devices) · 2026-08-12
Same hazard · data integrity
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- SevereCopan WASPLab Software Recall Over Results Overwrite Issue
FDA (Devices) · 2026-08-12
- SevereMedline spinal anesthesia trays recalled over Huons bupivacaine quality concerns
FDA (Devices) · 2026-06-03
- SevereMedline pain and Whitacre spinal trays recalled over bupivacaine concerns
FDA (Devices) · 2026-06-03