Z-2543-2025Class II

IntelliSpace Cardiovascular, Software 8.0.0.4

Name: Z-2543-2025 IntelliSpace Cardiovascular, Software 8.0.0.4
Creator: Philips Medical Systems Nederland B.V.
Published: 2025-08-08
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-08-08 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Nederland B.V. began a recall of IntelliSpace Cardiovascular, Software 8.0.0.4 on 2025-08-08. FDA classified it as Class II and gives the reason as "Software issue that results in the display of outdated information". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2543-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-08
Posted: 2025-09-09
Recalling firm: Philips Medical Systems Nederland B.V.
Product: IntelliSpace Cardiovascular, Software 8.0.0.4.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issue that results in the display of outdated information.
Root cause tag: software
FDA root cause: Software design
Action: 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 [email protected]. 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).
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of GA, NC & TX.
Product codes and lots: Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2543-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2543-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-09

Product code LLZ

K153022Class IIPhilips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV / cleared 2015-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)