IntelliSpace Cardiovascular (Philips) – outdated info (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntelliSpace Cardiovascular, Software 8.0.0.4.
Brand
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands
Lot Codes / Batch Numbers
Model No. 830089, UDI: (01)00884838122000(11)240325(10)8.0.0.0, Serial No. 2210, 2050, 463, 193.
Products Sold
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands is recalling IntelliSpace Cardiovascular, Software 8.0.0.4. due to Software issue that results in the display of outdated information.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software issue that results in the display of outdated information.
Recommended Action
Per FDA guidance
An URGENT Medical Device Correction notice dated 8/7/25 was mailed to consignees. The notification includes instructions for continued safe use of devices, which includes: 1. Ensure all finding codes with variables/modifiers are populated correctly on the report screen. Do not leave any FitB Modifier Code Fields Blank. 2. Verify report statements match the selections in the work area before finalizing report. Systems may continue to be used in accordance with the intended use and per the additional instructions. The provided recall notification is to be shared with all users of the device and retained with affected systems until the corrected software is installed. The provided recall response form should be returned within 30 days to Philips.recall@Philips.com. A Philips representative will call consignees to schedule a time to install the software solution (FCO83000218). Consignees with any questions can contact Philips Informatics Customer Support at 1-800-996-1328 (x1).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026