Z-1740-2025Class II

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089

Name: Z-1740-2025 IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089
Creator: Philips Medical Systems Nederland B.V.
Published: 2025-04-07
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-04-07 / Open, Classified / root cause: software

FDA source

Philips Medical Systems Nederland B.V. began a recall of IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089 on 2025-04-07. FDA classified it as Class II and gives the reason as "An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report". 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-1740-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-05-08
Recalling firm: Philips Medical Systems Nederland B.V.
Product: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: On April 7, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 1. Actions that should be taken by the customer / user in order to prevent risks for patients or users " Verify that text added into the report conclusion matches the data in the work area interpret sheet (Refer to Attachment A Screenshot 2) " You may continue to use your system(s) in accordance with the intended use and by following the recommendation above. " Circulate this notice to all users of this device so that they are aware of the potential issue. " Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Please review the workflows described in Attachment A and identify whether either workflow is currently in use, or planned to be used, at your facility. Please note your response in the attached customer response form. " If these are not planned to be used at this time, please contact Philips Informatics Customer Support and ensure that this correction is implemented before beginning to use these workflows. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: [email protected]. 2. Actions planned by Philips to correct the problem Once all customer responses have been received, a Philips representative will contact customers who use or may use the affected workflows to schedule a time to install the software solution on your system(s) to resolve the issue (reference FCO-TBD). Please be assured that maintaining the highest level of safety and quality is our greatest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: Philips Informatics Customer Support: 1-800-669-1328, Option 1. This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the us
Quantity in commerce: 996 units (267 US, 729 OUS)
Distribution: Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1740-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-08

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)