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

FDA device recall Z-1740-2025 · posted 2025-05-08 · Open, Classified

Recall details

Recalling firm

Philips Medical Systems Nederland B.V.

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.

Action taken

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: Philips.recall@philips.com. 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

Root cause

Software in the Use Environment

Status

Open, Classified

Product code

LLZ

Quantity affected

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, Mexic

Date initiated

2025-04-07

Date posted

2025-05-08

Location

Eindhoven, Netherlands

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