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Open, Classified

IntelliSpace Cardiovascular, Software 8.0.0.4.

FDA Recall Z-2543-2025 · Posted 2025-09-09

Recalling FirmPhilips Medical Systems Nederland B.V.
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-08-08
Product Quantity4 units

Reason for Recall

Software issue that results in the display of outdated information.

Firm 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).

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of GA, NC & TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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