Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands Philips IntelliSpace Cardiovascular software, Model 830089. Recall
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
Philips IntelliSpace Cardiovascular software, Model 830089.
Brand
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands
Lot Codes / Batch Numbers
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
Products Sold
Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands is recalling Philips IntelliSpace Cardiovascular software, Model 830089. due to Study data is not able to be archived, copied, or exported with the cardiovascular software version.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Recommended Action
Per FDA guidance
The recalling firm initially issued an "Important Product Notice" dated 3/12/2024 which their consignees received on 4/4/2024 informing them that Philips had identified an issue with the IntelliSpace Cardiovascular software version 7.0 where study data is not able to be archived, copied, or exported. The notice was to explain the issue and under what circumstances it can occur, the affected products and how to identify them, the actions the customer can take to minimize the effect of the issue, and the actions planned by Philips to correct the issue. The actions were: (1) The customer may continue to use the system in accordance with its intended use; (2) If study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD, update the "Reason for Study" field using less than 64 characters; (3) Circulate the notice to all users of the system so they are aware of the issue; and (4) Retain the letter with the system until Philips has implemented the software correction. Philips will contact the customer to schedule a time for a Field Service Engineer to visit their site and install a software solution to resolve the issue. No response form was enclosed. A follow-up Urgent Medical Device Correction letter dated 1/8/2025 was issued on 1/10/2025 to the U.S. consignees who have not yet received the software correction. The letter supersedes the initial 3/12/2024 letter. The 1/8/2025 letter contains updated information with respect to the potential hazard/harm associated with the issue based on the revised Health Hazard Evaluation (HHE Rev C, 02-Jan-2025). The letter also had a response form attached for completion and return no later than 30 days after receipt of the letter.
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