Z-1252-2025Class II

Philips IntelliSpace Cardiovascular software, Model 830089

Name: Z-1252-2025 Philips IntelliSpace Cardiovascular software, Model 830089
Creator: Philips Medical Systems Nederland B.V.
Published: 2024-04-04
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2024-04-04 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Nederland B.V. began a recall of Philips IntelliSpace Cardiovascular software, Model 830089 on 2024-04-04. FDA classified it as Class II and gives the reason as "Study data is not able to be archived, copied, or exported with the cardiovascular software version". 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-1252-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-04
Posted: 2025-02-28
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips IntelliSpace Cardiovascular software, Model 830089.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 139
Distribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
Product codes and lots: Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1252-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-02-28

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)